Phase 2
N=356
AGN-199201 for the Treatment of Erythema With Rosacea
Rosacea · Erythema
Bottom Line
View on ClinicalTrials.gov: NCT01735201 ↗Enrolled (actual)
356
Serious AEs
0.8%
Results posted
May 2014
Primary outcome: Primary: Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) — 13.3; 20.5; 22.7; 6.8 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AGN-199201 Dose A (Drug); AGN-199201 Dose B (Drug); AGN-199201 Dose C (Drug); AGN-199201 Vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA) |
13.3; 20.5; 22.7; 6.8; 8.9; 17.8 | — |
| SECONDARY Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 0.5 Hour Post-Dose on Day 28 |
6.7; 11.4; 6.8; 4.5; 6.7; 6.7 | — |
| SECONDARY Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 1 Hour Post-Dose on Day 28 |
11.1; 13.6; 18.2; 2.3; 6.7; 11.1 | — |
Summary
This study will evaluate the safety and efficacy of 3 doses of AGN-199201 once and twice daily compared to vehicle for the treatment of moderate to severe facial erythema associated with rosacea.
Eligibility Criteria
Inclusion Criteria
- Redness of the skin caused by rosacea
Exclusion Criteria
- ≥3 inflammatory lesions
- Laser light-source or other energy based therapy in the last 6 months
- Any prescription or over the counter product for the treatment of acne or rosacea in the last 14 days
Data sourced from ClinicalTrials.gov (NCT01735201). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.