Trial Outcomes & Findings for A Long-Term Safety and Efficacy Study AGN-19920 in Patients With Persistent Erythema Associated With Rosacea (NCT NCT02095158)
NCT ID: NCT02095158
Last Updated: 2019-11-18
Results Overview
An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A Treatment-Related Adverse Event is an Adverse Event determined by the investigator to be causally related to the study medication.
COMPLETED
PHASE3
440 participants
56 Weeks
2019-11-18
Participant Flow
Participant milestones
| Measure |
Oxymetazoline HCL Cream 1.0%
Oxymetazoline hydrogen chloride (HCL) Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
|
|---|---|
|
Overall Study
STARTED
|
440
|
|
Overall Study
COMPLETED
|
365
|
|
Overall Study
NOT COMPLETED
|
75
|
Reasons for withdrawal
| Measure |
Oxymetazoline HCL Cream 1.0%
Oxymetazoline hydrogen chloride (HCL) Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
14
|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Lost to Follow-up
|
20
|
|
Overall Study
Personal Reasons
|
35
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Other Miscellaneous Reasons
|
1
|
Baseline Characteristics
A Long-Term Safety and Efficacy Study AGN-19920 in Patients With Persistent Erythema Associated With Rosacea
Baseline characteristics by cohort
| Measure |
Oxymetazoline HCL Cream 1.0%
n=440 Participants
Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
|
|---|---|
|
Age, Customized
18 to 64 years
|
370 participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
70 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
335 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 56 WeeksPopulation: Safety population included all participants who received at least 1 dose of study medication.
An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A Treatment-Related Adverse Event is an Adverse Event determined by the investigator to be causally related to the study medication.
Outcome measures
| Measure |
Oxymetazoline HCL Cream 1.0%
n=440 Participants
Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
|
|---|---|
|
Percentage of Participants With Treatment-Related Adverse Events
|
8.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 1 Hours 3 and 6, Week 4 Predose and Hours 3 and 6, Week 12 Predose, Week 26 Predose and Hours 3 and 6, Week 39 Predose, Week 52 Predose and Hours 3 and 6, Week 54 PredosePopulation: Modified-intent-to-treat (mITT) population consisted of all participants who had at least 1 post-baseline CEA and SSA measurement.
The investigator assessed the participant's overall severity of erythema in the treatment area by using the 5-point CEA scale with photonumeric guide where: 0=clear skin with no signs of erythema (best) to 4=severe erythema; fiery redness (worst). A decrease in the score indicates improvement. The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants with at least a 2-grade decrease (improvement) on both CEA and SSA from Baseline was evaluated over the 6-hour evaluation period (hours 3 and 6) post-dose.
Outcome measures
| Measure |
Oxymetazoline HCL Cream 1.0%
n=440 Participants
Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
|
|---|---|
|
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales
Week 4 (Predose)
|
1.2 percentage of participants
|
|
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales
Day 1 (Hour 6)
|
17.8 percentage of participants
|
|
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales
Week 4 (Hour 3)
|
19.5 percentage of participants
|
|
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales
Week 12 (Predose)
|
6.1 percentage of participants
|
|
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales
Week 26 (Predose)
|
6.5 percentage of participants
|
|
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales
Week 26 (Hour 3)
|
34.7 percentage of participants
|
|
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales
Week 26 (Hour 6)
|
38.1 percentage of participants
|
|
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales
Week 39 (Predose)
|
9.5 percentage of participants
|
|
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales
Week 52 (Hour 3)
|
36.7 percentage of participants
|
|
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales
Week 52 (Hour 6)
|
43.4 percentage of participants
|
|
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales
Week 54 (Predose)
|
12.1 percentage of participants
|
|
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales
Week 4 (Hour 6)
|
23.0 percentage of participants
|
|
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales
Week 52 (Predose)
|
11.2 percentage of participants
|
|
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales
Day 1 (Hour 3)
|
11.6 percentage of participants
|
Adverse Events
Oxymetazoline HCL Cream 1.0%
Serious adverse events
| Measure |
Oxymetazoline HCL Cream 1.0%
n=440 participants at risk
Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
0.23%
1/440 • Up to 56 Weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.23%
1/440 • Up to 56 Weeks
|
|
General disorders
Chest pain
|
0.23%
1/440 • Up to 56 Weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.23%
1/440 • Up to 56 Weeks
|
|
Infections and infestations
Appendicitis
|
0.23%
1/440 • Up to 56 Weeks
|
|
Infections and infestations
Cellulitis
|
0.23%
1/440 • Up to 56 Weeks
|
|
Infections and infestations
Chronic sinusitis
|
0.23%
1/440 • Up to 56 Weeks
|
|
Infections and infestations
Sepsis
|
0.23%
1/440 • Up to 56 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.4%
6/440 • Up to 56 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.23%
1/440 • Up to 56 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.23%
1/440 • Up to 56 Weeks
|
|
Nervous system disorders
Parkinson's disease
|
0.23%
1/440 • Up to 56 Weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.23%
1/440 • Up to 56 Weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER