Trial Outcomes & Findings for A Study Comparing Two Topicals in the Treatment of Acne Vulgaris (NCT NCT03743038)

Last Updated: 2021-04-06

Results Overview

Severity of acne vulgaris was assessed by Investigator Global Assessment (IGA). The IGA score is a static evaluation of the overall severity or "average" degree of severity of a participant's disease by the Blinded Evaluator taking into account all of the participant's facial acne lesions as the participant appears on the day of the evaluation. Overall severity of acne was assessed using a five-point scale where 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Low score represented best outcome and higher score value indicated worst outcome.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

At Week 6

Results posted on

2021-04-06

Participant Flow

Study was conducted in one site at United States from November 20, 2018 to February 11, 2019.

The study consisted of a Screening/Baseline Visit, Visits at Weeks 1, 2, and 4, along with a Week 6/End of Treatment (EOT) Visit, and a Week 7/End of Study (EOS) Visit. All participants underwent inclusion and exclusion criteria assessment and all eligible participants signed the informed consent before undergoing any study related procedures. All assessments at screening were done as per the schedule of assessment.

Unit of analysis: Face sides

Participant milestones

Participant milestones
Measure	Overall Participants were randomized (1:1) and applied FMX101 hydrophobic oil based vehicle (Test Article A) topically on one side of the face and Hydro-alcohol solution based vehicle (Test Article B) on the contralateral side of the face once daily for six weeks.
Overall Study STARTED	12 24
Overall Study Test Article A	12 12
Overall Study Test Article B	12 12
Overall Study COMPLETED	11 22
Overall Study NOT COMPLETED	1 2

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall Participants were randomized (1:1) and applied FMX101 hydrophobic oil based vehicle (Test Article A) topically on one side of the face and Hydro-alcohol solution based vehicle (Test Article B) on the contralateral side of the face once daily for six weeks.
Overall Study Physician Decision	1

Baseline Characteristics

A Study Comparing Two Topicals in the Treatment of Acne Vulgaris

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=12 Participants Participants were randomized (1:1) and applied FMX101 hydrophobic oil based vehicle (Test Article A) topically on one side of the face and Hydro-alcohol solution based vehicle (Test Article B) on the contralateral side of the face once daily for six weeks on one side of the face.
Age, Continuous	20.1 Years STANDARD_DEVIATION 5.24 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 6

Population: The mITT population included all randomized participants who met all Inclusion/Exclusion criteria, applied at least one dose of test article, and returned for at least one post-Baseline evaluation visit. Here, overall number of participants analyzed presents only those participants who were analyzed for this particular outcome measure, and number analyzed presents the number of participants that were analyzed at specified week.

Outcome measures

Outcome measures
Measure	FMX101 Oil Vehicle (A) n=10 Face sides Participants applied FMX101 hydrophobic oil based vehicle (Test Article A) topically once daily for six weeks on one side of the face.	Hydro-alcohol Vehicle (B) n=10 Face sides Participants applied Hydro-alcohol solution based vehicle (Test Article B) topically once daily for six weeks on the contralateral side of the face.
Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6 0-Clear	0 Participants	0 Participants
Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6 1-Almost Clear	3 Participants	3 Participants
Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6 2-Mild	5 Participants	3 Participants
Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6 3-Moderate	3 Participants	5 Participants
Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6 4-Severe	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At Week 6

Severity of acne vulgaris was assessed by IGA. The IGA score is a static evaluation of the overall severity or "average" degree of severity of a participant's disease by the Blinded Evaluator taking into account all of the participant's facial acne lesions as the participant appears on the day of the evaluation. Overall severity of acne was assessed using a five-point scale where 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. The IGA treatment "success" was defined as at least a two-point improvement in IGA score relative to Baseline.

Outcome measures

Outcome measures
Measure	FMX101 Oil Vehicle (A) n=10 Face sides Participants applied FMX101 hydrophobic oil based vehicle (Test Article A) topically once daily for six weeks on one side of the face.	Hydro-alcohol Vehicle (B) n=10 Face sides Participants applied Hydro-alcohol solution based vehicle (Test Article B) topically once daily for six weeks on the contralateral side of the face.
Number of Participants Achieving Investigator's Global Assessments Treatment Success at Week 6	3 Participants	3 Participants

PRIMARY outcome

Timeframe: Day 1/ Baseline and Week 6

Inflammatory lesion count (ILC) included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material).

Outcome measures

Outcome measures
Measure	FMX101 Oil Vehicle (A) n=10 Face sides Participants applied FMX101 hydrophobic oil based vehicle (Test Article A) topically once daily for six weeks on one side of the face.	Hydro-alcohol Vehicle (B) n=10 Face sides Participants applied Hydro-alcohol solution based vehicle (Test Article B) topically once daily for six weeks on the contralateral side of the face.
Absolute Change From Baseline to Week 6 in Inflammatory Lesion Count	-7.5 Lesions Standard Deviation 8.26	-6.3 Lesions Standard Deviation 4.20

PRIMARY outcome

Timeframe: Day 1/ Baseline and Week 6

The ILC included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material).

Outcome measures

Outcome measures
Measure	FMX101 Oil Vehicle (A) n=10 Face sides Participants applied FMX101 hydrophobic oil based vehicle (Test Article A) topically once daily for six weeks on one side of the face.	Hydro-alcohol Vehicle (B) n=10 Face sides Participants applied Hydro-alcohol solution based vehicle (Test Article B) topically once daily for six weeks on the contralateral side of the face.
Percentage Change From Baseline to Week 6 in Inflammatory Lesion Count	-37.7 Percent Change Standard Deviation 42.88	-39.0 Percent Change Standard Deviation 30.83

PRIMARY outcome

Timeframe: Day 1/ Baseline and Week 6

The non-inflammatory lesion count (NILC) included open and closed comedones.

Outcome measures

Outcome measures
Measure	FMX101 Oil Vehicle (A) n=10 Face sides Participants applied FMX101 hydrophobic oil based vehicle (Test Article A) topically once daily for six weeks on one side of the face.	Hydro-alcohol Vehicle (B) n=10 Face sides Participants applied Hydro-alcohol solution based vehicle (Test Article B) topically once daily for six weeks on the contralateral side of the face.
Absolute Change From Baseline to Week 6 in Non-Inflammatory Lesion Count	-7.0 Lesions Standard Deviation 5.06	-5.0 Lesions Standard Deviation 4.36

PRIMARY outcome

Timeframe: Day 1/ Baseline and Week 6

The NILC included open and closed comedones.

Outcome measures

Outcome measures
Measure	FMX101 Oil Vehicle (A) n=10 Face sides Participants applied FMX101 hydrophobic oil based vehicle (Test Article A) topically once daily for six weeks on one side of the face.	Hydro-alcohol Vehicle (B) n=10 Face sides Participants applied Hydro-alcohol solution based vehicle (Test Article B) topically once daily for six weeks on the contralateral side of the face.
Percentage Change From Baseline to Week 6 in Non-Inflammatory Lesion Count	-33.2 Percent Change Standard Deviation 24.65	-24.0 Percent Change Standard Deviation 24.15

PRIMARY outcome

Timeframe: Day 1/Baseline and Weeks 2, 4, 6 and 7

Sebum measurement was conducted on the right and left side of the face. The sebum measurement represented the sebum score of saturation of the film and had a range of 0 to 99, where 99 equated to very oily skin.

Outcome measures

Outcome measures
Measure	FMX101 Oil Vehicle (A) n=12 Face sides Participants applied FMX101 hydrophobic oil based vehicle (Test Article A) topically once daily for six weeks on one side of the face.	Hydro-alcohol Vehicle (B) n=12 Face sides Participants applied Hydro-alcohol solution based vehicle (Test Article B) topically once daily for six weeks on the contralateral side of the face.
Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7 Week 2	1.6 Percentage (%) Standard Deviation 13.28	-2.5 Percentage (%) Standard Deviation 5.89
Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7 Week 4	6.0 Percentage (%) Standard Deviation 13.96	5.2 Percentage (%) Standard Deviation 8.14
Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7 Week 6	3.9 Percentage (%) Standard Deviation 8.88	1.9 Percentage (%) Standard Deviation 5.63
Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7 Week 7	-1.9 Percentage (%) Standard Deviation 8.24	-1.5 Percentage (%) Standard Deviation 7.57

PRIMARY outcome

Timeframe: Day 1/Baseline and Weeks 2, 4, 6 and 7

Transepidermal Water Loss (TEWL) was conducted on the right and left side of the face.

Outcome measures

Outcome measures
Measure	FMX101 Oil Vehicle (A) n=11 Face sides Participants applied FMX101 hydrophobic oil based vehicle (Test Article A) topically once daily for six weeks on one side of the face.	Hydro-alcohol Vehicle (B) n=11 Face sides Participants applied Hydro-alcohol solution based vehicle (Test Article B) topically once daily for six weeks on the contralateral side of the face.
Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7 Week 2	2.8 g/m^2 /h Standard Deviation 7.12	-0.4 g/m^2 /h Standard Deviation 5.62
Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7 Week 4	1.3 g/m^2 /h Standard Deviation 6.86	-1.2 g/m^2 /h Standard Deviation 6.46
Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7 Week 6	-0.7 g/m^2 /h Standard Deviation 7.92	-0.6 g/m^2 /h Standard Deviation 7.24
Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7 Week 7	0.8 g/m^2 /h Standard Deviation 6.28	-1.7 g/m^2 /h Standard Deviation 7.29

PRIMARY outcome

Timeframe: Day 1 until Week 7 (End of Study) and Unscheduled Visit

Population: Safety population included all randomized participants who received test article and applied at least one application.

An adverse event is any untoward medical occurrence associated with the use of a drug in participants, whether or not considered drug related.

Outcome measures

Outcome measures
Measure	FMX101 Oil Vehicle (A) n=12 Participants Participants applied FMX101 hydrophobic oil based vehicle (Test Article A) topically once daily for six weeks on one side of the face.	Hydro-alcohol Vehicle (B) Participants applied Hydro-alcohol solution based vehicle (Test Article B) topically once daily for six weeks on the contralateral side of the face.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Any TEAEs	5 Participants	—
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Any Treatment Related TEAEs	0 Participants	—
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) TEAEs Within the Treatment Area	0 Participants	—
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Serious TEAEs	0 Participants	—

PRIMARY outcome

Timeframe: Day 1 until Week 7 (End of Study) or Unscheduled Visit

Population: Safety population included all randomized participants who received test article and applied at least one application. Here, overall number of participants analyzed presents only those participants who were analyzed for particular outcome measure, and number analyzed presents the number of participants that were analyzed at specified week.

The local skin reactions (LSRs) included erythema, edema, scaling/dryness, burning/stinging, pruritus, erosion, and pain) were assessed. Erythema, edema, scaling/dryness, and erosion were assessed by the investigator and burning/stinging, pain, and pruritus were assessed by the participant. Assessments was made using a 4-point ordinal scale where 0=absent, 1=mild (slight, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). Here, lower point represented no reaction and higher points represented severe reactions.The LSRs were assessed both before and 15 minutes following test article application.

Outcome measures

Outcome measures
Measure	FMX101 Oil Vehicle (A) n=11 Participants Participants applied FMX101 hydrophobic oil based vehicle (Test Article A) topically once daily for six weeks on one side of the face.	Hydro-alcohol Vehicle (B) n=11 Participants Participants applied Hydro-alcohol solution based vehicle (Test Article B) topically once daily for six weeks on the contralateral side of the face.
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Erosion, Week 2 (Improved/Same)	11 Participants	11 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Erosion, Week 2 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Erosion, Week 1 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Erythema, Week 1 (Improved/Same)	9 Participants	9 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Erythema, Week 1 (Worsened)	1 Participants	1 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Erythema, Week 2 (Improved/Same)	11 Participants	11 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Erythema, Week 2 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Erythema, Week 4 (Improved/Same)	9 Participants	9 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Erythema, Week 4 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Erythema, Week 6 (Improved/Same)	10 Participants	10 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Erythema, Week 6 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Erythema, Week 7 (Improved/Same)	11 Participants	11 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Erythema, Week 7 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Edema, Week 1 (Improved/Same)	10 Participants	10 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Edema, Week 1 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Edema, Week 2 (Improved/Same)	11 Participants	11 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Edema, Week 2 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Edema, Week 4 (Improved/Same)	9 Participants	9 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Edema, Week 4 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Edema, Week 6 (Improved/Same)	10 Participants	10 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Edema, Week 6 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Edema, Week 7 (Improved/Same)	11 Participants	11 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Edema, Week 7 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Scaling/Dryness, Week 1 (Improved/Same)	10 Participants	9 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Scaling/Dryness, Week 1 (Worsened)	0 Participants	1 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Scaling/Dryness, Week 2 (Improved/Same)	9 Participants	8 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Scaling/Dryness, Week 2 (Worsened)	2 Participants	3 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Scaling/Dryness, Week 4 (Improved/Same)	9 Participants	9 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Scaling/Dryness, Week 4 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Scaling/Dryness, Week 6 (Improved/Same)	9 Participants	8 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Scaling/Dryness, Week 6 (Worsened)	1 Participants	2 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Scaling/Dryness, Week 7 (Improved/Same)	10 Participants	11 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Scaling/Dryness, Week 7 (Worsened)	1 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Erosion, Week 1 (Improved/Same)	10 Participants	10 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Erosion, Week 4 (Improved/Same)	9 Participants	9 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Erosion, Week 4 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Erosion, Week 6 (Improved/Same)	10 Participants	10 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Erosion, Week 6 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Erosion, Week 7 (Improved/Same)	11 Participants	11 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Erosion, Week 7 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Burning/Stinging, Week 1 (Improved/Same)	10 Participants	10 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Burning/Stinging, Week 1 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Burning/Stinging, Week 2 (Improved/Same)	11 Participants	10 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Burning/Stinging, Week 2 (Worsened)	0 Participants	1 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Burning/Stinging, Week 4 (Improved/Same)	9 Participants	9 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Burning/Stinging, Week 4 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Burning/Stinging, Week 6 (Improved/Same)	10 Participants	10 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Burning/Stinging, Week 6 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Burning/Stinging, Week 7 (Improved/Same)	11 Participants	11 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Burning/Stinging, Week 7 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Pain, Week 1 (Improved/Same)	10 Participants	10 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Pain, Week 1 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Pain, Week 2 (Improved/Same)	11 Participants	11 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Pain, Week 2 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Pain, Week 4 (Improved/Same)	9 Participants	9 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Pain, Week 4 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Pain, Week 6 (Improved/Same)	10 Participants	10 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Pain, Week 6 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Pain, Week 7 (Improved/Same)	11 Participants	11 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Pain, Week 7 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Pruritus, Week 1 (Improved/Same)	10 Participants	10 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Pruritus, Week 1 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Pruritus, Week 2 (Improved/Same)	11 Participants	11 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Pruritus, Week 2 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Pruritus, Week 4 (Improved/Same)	9 Participants	9 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Pruritus, Week 4 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Pruritus, Week 6 (Improved/Same)	10 Participants	10 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Pruritus, Week 6 (Worsened)	0 Participants	0 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Pruritus, Week 7 (Improved/Same)	11 Participants	11 Participants
Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline Pruritus, Week 7 (Worsened)	0 Participants	0 Participants

Adverse Events

Overall

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Overall n=12 participants at risk Participants were randomized (1:1) and applied FMX101 hydrophobic oil based vehicle (Test Article A) topically on one side of the face and Hydro-alcohol solution based vehicle (Test Article B) on the contralateral side of the face once daily for six weeks.
Gastrointestinal disorders Gastroenteritis Viral	8.3% 1/12 • Day 1 until Week 7 (End of Study) or Unscheduled Visit Adverse Events were only monitored/assessed on the whole participant level.
Infections and infestations Influenza	8.3% 1/12 • Day 1 until Week 7 (End of Study) or Unscheduled Visit Adverse Events were only monitored/assessed on the whole participant level.
Infections and infestations Sinusitis	8.3% 1/12 • Day 1 until Week 7 (End of Study) or Unscheduled Visit Adverse Events were only monitored/assessed on the whole participant level.
Infections and infestations Upper Respiratory Tract Infection	25.0% 3/12 • Day 1 until Week 7 (End of Study) or Unscheduled Visit Adverse Events were only monitored/assessed on the whole participant level.

Additional Information

Iain Stuart, PhD.

Foamix Pharmaceuticals, Inc.

Phone: 1 800-775-7936

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60