Trial Outcomes & Findings for Atralin Gel for the Treatment of Rosacea (NCT NCT01125930)

NCT ID: NCT01125930

Last Updated: 2014-07-16

Results Overview

Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 68 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2014-07-16

Participant Flow

Participant milestones

Measure	Vehicle Gel Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Study STARTED	22	46
Overall Study COMPLETED	21	36
Overall Study NOT COMPLETED	1	10

Reasons for withdrawal

Measure	Vehicle Gel Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Overall Study Adverse Event	0	1
Overall Study Withdrawal by Subject	1	6
Overall Study Protocol Violation	0	1
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Atralin Gel for the Treatment of Rosacea

Baseline characteristics by cohort

Measure	Vehicle Gel n=22 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=46 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Total n=68 Participants Total of all reporting groups
Age, Continuous	55.00 years STANDARD_DEVIATION 11.24 • n=5 Participants	56.09 years STANDARD_DEVIATION 11.58 • n=7 Participants	55.74 years STANDARD_DEVIATION 11.39 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	39 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian, European descent	22 participants n=5 Participants	43 participants n=7 Participants	65 participants n=5 Participants
Race/Ethnicity, Customized Caucasian, non-European descent	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Middle Eastern	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	46 participants n=7 Participants	68 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Last Observation Carried Forward (LOCF), Complete-Case Intent-to-Treat (ITT) Population

Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin

Outcome measures

Measure	Vehicle Gel n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema) None	0 participants	0 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema) Mild Erythema	12 participants	22 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema) Moderate Erythema	9 participants	13 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema) Marked Erythema	0 participants	1 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema) Deep Erythema	0 participants	0 participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 24 weeks

Population: LOCF, Complete-Case ITT population

Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin

Outcome measures

Measure	Vehicle Gel n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia Severe	0 participants	1 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia None	1 participants	0 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia Mild	10 participants	22 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia Moderate	10 participants	13 participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 24 weeks

Population: LOCF, Complete-Case ITT Population

Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin

Outcome measures

Measure	Vehicle Gel n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema None	21 participants	31 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema Mild	0 participants	5 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema Moderate	0 participants	0 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema Severe	0 participants	0 participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 24 weeks

Population: LOCF, Complete-Case ITT Population

Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin

Outcome measures

Measure	Vehicle Gel n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin None	13 participants	16 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin Slight Flaking	7 participants	12 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin Moderate Flaking/Scaling	1 participants	8 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin Marked Scaling/Fissuring	0 participants	0 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin Severe Scaling/Fissuring	0 participants	0 participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 24 weeks

Population: LOCF, Complete Case ITT Population

Flushing is defined as a temporary redness of the face, neck and chest. Subjects were asked to choose the best answer that applied to them in response to the questions "Do you have flushing?".

Outcome measures

Measure	Vehicle Gel n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing Yes	19 participants	33 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing No	2 participants	3 participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 24 weeks

Population: LOCF, Complete-Case ITT Population

Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the facial burning feature of their rosacea.

Outcome measures

Measure	Vehicle Gel n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning None	15 participants	28 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning Mild	6 participants	7 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning Moderate	0 participants	1 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning Severe	0 participants	0 participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 24 weeks

Population: LOCF, Complete-Case ITT Population

Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the Facial Stinging feature of their rosacea.

Outcome measures

Measure	Vehicle Gel n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging None	17 participants	27 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging Mild	4 participants	8 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging Moderate	0 participants	1 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging Severe	0 participants	0 participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 24 weeks

Population: LOCF, Complete-Case ITT Population

Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to give an overall self-assessment of product tolerance.

Outcome measures

Measure	Vehicle Gel n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product Strongly like product	2 participants	8 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product Like product	7 participants	7 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product Neutral	9 participants	16 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product Dislike product	3 participants	5 participants	—	—	—	—	—	—	—	—
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product Strongly dislike product	0 participants	0 participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 2, 6, 12, 18, 24 weeks

Population: LOCF, Complete-Case ITT Population

The Dermatology Life Quality Index (DLQI) questionnaire was given at each visit. It involves 10 questions that relate to symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. The total DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

Outcome measures

Measure	Vehicle Gel n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Quality of Life	2.62 units on a scale Standard Deviation 3.01	2.28 units on a scale Standard Deviation 2.31	2.19 units on a scale Standard Deviation 2.36	2.44 units on a scale Standard Deviation 2.21	1.95 units on a scale Standard Deviation 2.25	2.03 units on a scale Standard Deviation 1.92	1.52 units on a scale Standard Deviation 1.63	2.14 units on a scale Standard Deviation 2.26	1.43 units on a scale Standard Deviation 1.60	2.14 units on a scale Standard Deviation 2.43

SECONDARY outcome

Timeframe: 24 weeks

Population: LOCF, Complete-Case ITT Population

Photodamage was measured at baseline and Week 24 visits using the nine point Hamilton-Griffiths Photoaging Score categories. The categories were developed using photographs of subject representing grades of photodamge from none (0) to severe (8). A direct comparison is made between the subject and the photographic standards. If an exact match cannot be made, the interstandard scores (1, 3, 5, 7) are used.

Outcome measures

Measure	Vehicle Gel n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Photodamage Score of 0, No Photo Damage	0 participants	0 participants	—	—	—	—	—	—	—	—
Photodamage Score of 1, Mild Photo Damage, < score of 2	3 participants	1 participants	—	—	—	—	—	—	—	—
Photodamage Score of 2, Mild Photo Damage	5 participants	11 participants	—	—	—	—	—	—	—	—
Photodamage Score of 3, Mild Photo Damage, > score of 2	4 participants	12 participants	—	—	—	—	—	—	—	—
Photodamage Score of 4, Moderate Photo Damage	5 participants	9 participants	—	—	—	—	—	—	—	—
Photodamage Score of 5, Moderate Photo Damage, > score of 4	2 participants	2 participants	—	—	—	—	—	—	—	—
Photodamage Score of 6, Moderate/Severe Photo Damage	2 participants	1 participants	—	—	—	—	—	—	—	—
Photodamage Score of 7, Severe Photo Damage, < score of 8	0 participants	0 participants	—	—	—	—	—	—	—	—
Photodamage Score of 8, Severe Photo Damage	0 participants	0 participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 2, 6, 12, 18 and 24 weeks

Population: LOCF, Complete-Case ITT Population

Signs of other rosacea subtypes using rosacea clinical scores: ocular manifestations of rosacea

Outcome measures

Measure	Vehicle Gel n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea None	18 participants	32 participants	19 participants	31 participants	18 participants	32 participants	19 participants	32 participants	19 participants	34 participants
Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea Mild	3 participants	4 participants	2 participants	4 participants	3 participants	4 participants	2 participants	4 participants	1 participants	2 participants
Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea Moderate	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants
Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea Severe	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 2, 6, 12, 18 and 24 weeks

Population: LOCF, Complete-Case ITT Population

Signs of other rosacea subtypes using rosacea clinical scores: phymatous changes of rosacea

Outcome measures

Measure	Vehicle Gel n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea None	21 participants	34 participants	21 participants	34 participants	21 participants	34 participants	21 participants	34 participants	21 participants	35 participants
Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea Mild	0 participants	2 participants	0 participants	2 participants	0 participants	2 participants	0 participants	2 participants	0 participants	1 participants
Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea Moderate	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 2, 6, 12, 18, 24 weeks

Population: LOCF, Complete-Case ITT Population

Signs of other rosacea subtypes includes papulopustular, inflammatory papule count

Outcome measures

Measure	Vehicle Gel n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Signs of Other Rosacea Subtypes: Papulopustular	0.19 inflammatory papule Standard Deviation 0.51	0.25 inflammatory papule Standard Deviation 0.73	0.14 inflammatory papule Standard Deviation 0.48	0.28 inflammatory papule Standard Deviation 0.66	0.43 inflammatory papule Standard Deviation 0.87	0.50 inflammatory papule Standard Deviation 1.59	0.48 inflammatory papule Standard Deviation 0.87	0.64 inflammatory papule Standard Deviation 1.59	0.38 inflammatory papule Standard Deviation 0.67	1.03 inflammatory papule Standard Deviation 2.69

SECONDARY outcome

Timeframe: 24 weeks

Population: ITT Population that completed baseline and Week 24 biopsies

These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of inflammation include Tachykinin 1 (TAC1), CXC Motif Receptor 4 (CXCR4), CXC Motif Ligand 12 (CXCL12), and Tumor Necrosis Factor Alpha (TNFa).

Outcome measures

Measure	Vehicle Gel n=7 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=9 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Molecular Markers of Inflammation TAC1 Fold Change Score	2.91 fold change Standard Deviation 1.94	0.87 fold change Standard Deviation 0.90	—	—	—	—	—	—	—	—
Molecular Markers of Inflammation CXCR4 Fold Change Score	1.39 fold change Standard Deviation 1.18	1.88 fold change Standard Deviation 1.81	—	—	—	—	—	—	—	—
Molecular Markers of Inflammation CXCL12 Fold Change Score	1.10 fold change Standard Deviation 0.80	1.20 fold change Standard Deviation 0.59	—	—	—	—	—	—	—	—
Molecular Markers of Inflammation TNFa Fold Change Score	1.24 fold change Standard Deviation 0.84	1.17 fold change Standard Deviation 0.97	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 24 weeks

Population: ITT Population that completed baseline and week 24 biopsies

These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of photodamage include Collagen 1 (COL-1), Collagen 3 (COL-3), Matrix Metalloproteinase 1 (MMP1), Matrix Metalloproteinase 3 (MMP3), and Matrix Metalloproteinase 9 (MMP9).

Outcome measures

Measure	Vehicle Gel n=7 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=9 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Molecular Evidence of Photodamage COL-1 Fold Change Score	1.50 fold change Standard Deviation 1.09	1.17 fold change Standard Deviation 0.65	—	—	—	—	—	—	—	—
Molecular Evidence of Photodamage COL-3 Fold Change Score	1.39 fold change Standard Deviation 0.77	1.04 fold change Standard Deviation 0.63	—	—	—	—	—	—	—	—
Molecular Evidence of Photodamage MMP1 Fold Change Score	1.44 fold change Standard Deviation 1.28	0.83 fold change Standard Deviation 0.60	—	—	—	—	—	—	—	—
Molecular Evidence of Photodamage MMP3 Fold Change Score	2.87 fold change Standard Deviation 3.58	0.69 fold change Standard Deviation 0.64	—	—	—	—	—	—	—	—
Molecular Evidence of Photodamage MMP9 Fold Change Score	2.53 fold change Standard Deviation 4.16	1.67 fold change Standard Deviation 1.60	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 2, 6, 12, 18 weeks

Population: LOCF, Complete-Case ITT Population

Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.

Outcome measures

Measure	Vehicle Gel n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) Mild Erythema	11 participants	18 participants	11 participants	16 participants	12 participants	20 participants	11 participants	23 participants	—	—
Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) Moderate Erythema	10 participants	17 participants	9 participants	18 participants	8 participants	14 participants	9 participants	11 participants	—	—
Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) Marked Erythema	0 participants	0 participants	0 participants	1 participants	0 participants	2 participants	0 participants	2 participants	—	—
Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) Deep Erythema	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—	—
Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness) None	0 participants	1 participants	1 participants	1 participants	1 participants	0 participants	1 participants	0 participants	—	—

SECONDARY outcome

Timeframe: 2, 6, 12, 18 weeks

Population: LOCF, Complete-Case ITT Population

Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.

Outcome measures

Measure	Vehicle Gel n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Severity of Erythematotelangiectatic Signs: Telangiectasia None	0 participants	0 participants	1 participants	0 participants	1 participants	0 participants	1 participants	0 participants	—	—
Severity of Erythematotelangiectatic Signs: Telangiectasia Mild	7 participants	17 participants	9 participants	19 participants	10 participants	20 participants	10 participants	21 participants	—	—
Severity of Erythematotelangiectatic Signs: Telangiectasia Moderate	14 participants	18 participants	11 participants	16 participants	10 participants	15 participants	10 participants	14 participants	—	—
Severity of Erythematotelangiectatic Signs: Telangiectasia Severe	0 participants	1 participants	0 participants	1 participants	0 participants	1 participants	0 participants	1 participants	—	—

SECONDARY outcome

Timeframe: 2, 6, 12, 18 weeks

Population: LOCF, Complete-Case ITT Population

Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.

Outcome measures

Measure	Vehicle Gel n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Severity of Erythematotelangiectatic Signs: Facial Edema None	21 participants	33 participants	21 participants	33 participants	21 participants	31 participants	21 participants	32 participants	—	—
Severity of Erythematotelangiectatic Signs: Facial Edema Mild	0 participants	2 participants	0 participants	3 participants	0 participants	5 participants	0 participants	4 participants	—	—
Severity of Erythematotelangiectatic Signs: Facial Edema Moderate	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—	—
Severity of Erythematotelangiectatic Signs: Facial Edema Severe	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	—	—

SECONDARY outcome

Timeframe: 2, 6, 12, 18 weeks

Population: LOCF, Complete-Case ITT Population

Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.

Outcome measures

Measure	Vehicle Gel n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Severity of Erythematotelangiectatic Signs: Dryness/Irritation None	8 participants	13 participants	13 participants	13 participants	12 participants	10 participants	13 participants	14 participants	—	—
Severity of Erythematotelangiectatic Signs: Dryness/Irritation Slight Flaking	12 participants	17 participants	7 participants	19 participants	8 participants	18 participants	6 participants	14 participants	—	—
Severity of Erythematotelangiectatic Signs: Dryness/Irritation Moderate Flaking/Scaling	1 participants	5 participants	1 participants	3 participants	1 participants	7 participants	2 participants	8 participants	—	—
Severity of Erythematotelangiectatic Signs: Dryness/Irritation Marked Scaling/Fissuring	0 participants	1 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants	—	—
Severity of Erythematotelangiectatic Signs: Dryness/Irritation Severe Scaling/Fissuring	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	—	—

SECONDARY outcome

Timeframe: 2, 6, 12, 18 weeks

Population: LOCF, Complete-Case ITT Population

Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance

Outcome measures

Measure	Vehicle Gel n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing Yes	17 participants	34 participants	18 participants	32 participants	18 participants	32 participants	18 participants	34 participants	—	—
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing No	4 participants	2 participants	3 participants	4 participants	3 participants	4 participants	3 participants	2 participants	—	—

SECONDARY outcome

Timeframe: 2, 6, 12, 18 weeks

Population: LOCF, Complete-Case ITT Population

Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance

Outcome measures

Measure	Vehicle Gel n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning None	16 participants	26 participants	17 participants	24 participants	16 participants	23 participants	16 participants	24 participants	—	—
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning Mild	3 participants	7 participants	3 participants	10 participants	5 participants	8 participants	5 participants	10 participants	—	—
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning Moderate	2 participants	2 participants	1 participants	1 participants	0 participants	5 participants	0 participants	2 participants	—	—
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning Severe	0 participants	1 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants	—	—

SECONDARY outcome

Timeframe: 2, 6, 12, 18 weeks

Population: LOCF, Complete-Case ITT Population

Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance

Outcome measures

Measure	Vehicle Gel n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging None	17 participants	25 participants	19 participants	24 participants	19 participants	26 participants	19 participants	26 participants	—	—
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging Mild	4 participants	10 participants	2 participants	10 participants	2 participants	9 participants	2 participants	8 participants	—	—
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging Moderate	0 participants	0 participants	0 participants	2 participants	0 participants	0 participants	0 participants	2 participants	—	—
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging Severe	0 participants	1 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	—	—

SECONDARY outcome

Timeframe: 2, 6, 12, 18 weeks

Population: LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.

Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance

Outcome measures

Measure	Vehicle Gel n=20 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment Strongly like product	0 participants	3 participants	2 participants	3 participants	2 participants	5 participants	1 participants	7 participants	—	—
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment Like product	3 participants	8 participants	4 participants	9 participants	4 participants	11 participants	5 participants	9 participants	—	—
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment Neutral	17 participants	23 participants	13 participants	20 participants	12 participants	18 participants	13 participants	18 participants	—	—
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment Dislike product	0 participants	2 participants	2 participants	4 participants	2 participants	2 participants	2 participants	2 participants	—	—
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment Strongly dislike product	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	—	—

SECONDARY outcome

Timeframe: 2, 6, 12, 18 weeks

Population: LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.

Outcome measures

Measure	Vehicle Gel n=20 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Skin Irritation Assessed by Facial Stinging Upon Product Application No stinging	17 participants	24 participants	20 participants	20 participants	20 participants	25 participants	19 participants	25 participants	—	—
Skin Irritation Assessed by Facial Stinging Upon Product Application A little stinging	3 participants	12 participants	1 participants	15 participants	1 participants	9 participants	2 participants	11 participants	—	—
Skin Irritation Assessed by Facial Stinging Upon Product Application A lot of stinging	0 participants	0 participants	0 participants	1 participants	0 participants	2 participants	0 participants	0 participants	—	—

SECONDARY outcome

Timeframe: 2, 6, 12, 18 weeks

Population: LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.

Outcome measures

Measure	Vehicle Gel n=20 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Skin Irritation Assessed by Facial Itching Upon Product Application No itching	18 participants	31 participants	21 participants	27 participants	21 participants	30 participants	21 participants	31 participants	—	—
Skin Irritation Assessed by Facial Itching Upon Product Application A little itching	2 participants	5 participants	0 participants	7 participants	0 participants	5 participants	0 participants	4 participants	—	—
Skin Irritation Assessed by Facial Itching Upon Product Application A lot of itching	0 participants	0 participants	0 participants	2 participants	0 participants	1 participants	0 participants	1 participants	—	—

SECONDARY outcome

Timeframe: 2, 6, 12, 18 weeks

Population: LOCF, Complete-Case ITT Population One subject did not complete the product assessment questionnaire at week 2 visit.

Outcome measures

Measure	Vehicle Gel n=20 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 6 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 6 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 12 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 12 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 18 n=21 Participants Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 18 n=36 Participants Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.	Vehicle Gel at Week 24 Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel at Week 24 Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Skin Irritation Assessed by Facial Burning Upon Product Application A little burning	3 participants	7 participants	2 participants	10 participants	1 participants	10 participants	2 participants	6 participants	—	—
Skin Irritation Assessed by Facial Burning Upon Product Application A lot of burning	0 participants	1 participants	0 participants	0 participants	0 participants	2 participants	0 participants	1 participants	—	—
Skin Irritation Assessed by Facial Burning Upon Product Application No burning	17 participants	28 participants	19 participants	26 participants	20 participants	24 participants	19 participants	29 participants	—	—

Adverse Events

Vehicle Gel

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Atralin Gel

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vehicle Gel n=22 participants at risk Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=46 participants at risk Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Surgical and medical procedures Right Hip Osteoarthritis	0.00% 0/22 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	2.2% 1/46 • Number of events 1 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.

Other adverse events

Measure	Vehicle Gel n=22 participants at risk Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.	Atralin Gel n=46 participants at risk Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Eye disorders Tearing of the eyes	0.00% 0/22 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	2.2% 1/46 • Number of events 1 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Eye disorders Blurry Vision	4.5% 1/22 • Number of events 1 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	0.00% 0/46 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Gastrointestinal disorders Hernia	0.00% 0/22 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	2.2% 1/46 • Number of events 1 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Gastrointestinal disorders Vomiting	0.00% 0/22 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	2.2% 1/46 • Number of events 2 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Gastrointestinal disorders Acid GI Reflux	0.00% 0/22 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	2.2% 1/46 • Number of events 2 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Gastrointestinal disorders Nausea	4.5% 1/22 • Number of events 1 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	0.00% 0/46 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Infections and infestations Upper Respiratory Tract Infection	27.3% 6/22 • Number of events 8 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	19.6% 9/46 • Number of events 11 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Infections and infestations Stomach Flu	9.1% 2/22 • Number of events 2 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	4.3% 2/46 • Number of events 2 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Infections and infestations Urinary Tract Infection	0.00% 0/22 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	2.2% 1/46 • Number of events 1 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Infections and infestations Head Lice	0.00% 0/22 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	2.2% 1/46 • Number of events 1 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Infections and infestations Stye	4.5% 1/22 • Number of events 1 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	0.00% 0/46 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Infections and infestations GI Distress	4.5% 1/22 • Number of events 1 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	0.00% 0/46 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Injury, poisoning and procedural complications Infection	0.00% 0/22 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	2.2% 1/46 • Number of events 1 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Musculoskeletal and connective tissue disorders Back Disc Pain	0.00% 0/22 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	2.2% 1/46 • Number of events 1 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/22 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	2.2% 1/46 • Number of events 1 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Musculoskeletal and connective tissue disorders Arthritis Flare	0.00% 0/22 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	2.2% 1/46 • Number of events 1 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Musculoskeletal and connective tissue disorders Heel Spur	4.5% 1/22 • Number of events 1 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	0.00% 0/46 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Nervous system disorders Headache	0.00% 0/22 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	4.3% 2/46 • Number of events 2 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Nervous system disorders Decreased Memory	4.5% 1/22 • Number of events 1 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	0.00% 0/46 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Psychiatric disorders Anxiety/Depression	0.00% 0/22 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	4.3% 2/46 • Number of events 2 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Vascular disorders Hypertension	4.5% 1/22 • Number of events 1 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	0.00% 0/46 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Respiratory, thoracic and mediastinal disorders Congestion	4.5% 1/22 • Number of events 1 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	10.9% 5/46 • Number of events 5 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Respiratory, thoracic and mediastinal disorders Asthma Flare	0.00% 0/22 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	2.2% 1/46 • Number of events 1 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Skin and subcutaneous tissue disorders Irritiated Skin	0.00% 0/22 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	10.9% 5/46 • Number of events 5 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Skin and subcutaneous tissue disorders Eczema/Atopic Dermatitis	9.1% 2/22 • Number of events 3 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	10.9% 5/46 • Number of events 6 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Skin and subcutaneous tissue disorders Actinic Keratosis	9.1% 2/22 • Number of events 2 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	6.5% 3/46 • Number of events 4 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Skin and subcutaneous tissue disorders Papular Inflammatory Flare	0.00% 0/22 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	15.2% 7/46 • Number of events 9 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Skin and subcutaneous tissue disorders Nail Disease	0.00% 0/22 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	4.3% 2/46 • Number of events 2 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Skin and subcutaneous tissue disorders Basal Cell Carcinoma	0.00% 0/22 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	2.2% 1/46 • Number of events 1 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
Skin and subcutaneous tissue disorders Inflamed Lesion/Cysts	0.00% 0/22 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	13.0% 6/46 • Number of events 6 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.
General disorders Numbness on Tongue	4.5% 1/22 • Number of events 1 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.	0.00% 0/46 • Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.

Additional Information

Dr. Lisa Maier

University of Michigan

Phone: 734-936-4192

Email: maierl@med.umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60