Phase 3
N=440
Efficacy and Safety of AGN-199201 in Patients With Persistent Erythema Associated With Rosacea
Erythema · Rosacea
Bottom Line
View on ClinicalTrials.gov: NCT02131636 ↗Enrolled (actual)
440
Serious AEs
0.9%
Results posted
Mar 2016
Primary outcome: Primary: Percentage of Patients With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) 5-point Scales — 11.9; 5.5; 15.5; 8.3 Percentage of Patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AGN-199201 (Drug); Vehicle to AGN-199201 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) 5-point Scales |
11.9; 5.5; 15.5; 8.3; 17.7; 6.0 | — |
| SECONDARY Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale |
20.1; 11.1; 23.3; 12.9; 23.3; 12.0 | — |
| SECONDARY Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA) |
-21.37; 61.54; -14.22; 75.09; -8.00; 71.18 | — |
| SECONDARY Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9 |
45.9; 27.5; 43.7; 24.3; 43.2; 23.4 | — |
| SECONDARY Change From Baseline on the SA-RFR Questionnaire Item #4 |
1.8; 1.9; -1.5; -1.5; -1.5; -1.5 | — |
| SECONDARY Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale |
30.2; 17.4 | — |
Summary
This study will evaluate the safety and efficacy of AGN-199201 once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea.
Eligibility Criteria
Inclusion Criteria
-Moderate to severe persistent facial erythema associated with rosacea.
Exclusion Criteria
- Greater than 3 inflammatory lesions on the face
- Current treatment with monoamine oxidase (MAO) inhibitors
- Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or Sjogren's syndrome.
Data sourced from ClinicalTrials.gov (NCT02131636). 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.