Phase 1
N=64
Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With Rosacea
Rosacea · Erythema
Bottom Line
View on ClinicalTrials.gov: NCT01579084 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: 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 Percentage of responders
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- AGN-199201 Formulation A (Drug); AGN-199201 Formulation B (Drug); AGN-199201 Formulation C (Drug); AGN-199201 Vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jun 2012
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 | — |
Summary
This study will evaluate the safety and tolerability of AGN-199201 for the treatment of erythema associated with rosacea.
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.