Phase 1
Completed N=64
Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With Rosacea
Rosacea · Erythema
Source: ClinicalTrials.gov NCT01579084 ↗
Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcomePrimary: Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1 — 15.6; 21.9; 28.1; 0.0 Percentage of responders
Summary
This study will evaluate the safety and tolerability of AGN-199201 for the treatment of erythema associated with rosacea.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1 |
15.6; 21.9; 28.1; 0.0 | — |
| PRIMARY Percentage of Responders With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 5 |
6.3; 6.5; 6.5; 3.1 | — |
| SECONDARY Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA |
34.4; 34.4; 40.6; 0.0; 15.6; 6.5 | — |
| SECONDARY Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA |
31.3; 46.9; 56.3; 3.1; 34.4; 41.9 | — |
Eligibility Criteria
Inclusion Criteria
- facial erythema associated with rosacea on both sides of the face
Exclusion Criteria
- Laser light-source or other energy based therapy in the last 6 months
- Excessive hair around the treatment area
Data sourced from ClinicalTrials.gov (NCT01579084). 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. Informational only — not medical advice.