Phase 3
Completed N=243
Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance
Source: ClinicalTrials.gov NCT00687908 ↗Enrolled (actual)
243
Serious AEs
0.8%
Results posted
Sep 2010
Primary outcomePrimary: Maintenance Success for Total Lesions at Week 24 — 78.9; 45.8 percent of subjects
Summary
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline Hyclate 100 mg. The safety of the two investigational treatments will also be assessed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maintenance Success for Total Lesions at Week 24 |
78.9; 45.8 | — |
| SECONDARY Maintenance Success for Inflamatory Lesions at Week 24 |
78; 48.3 | — |
| SECONDARY Maintenance Success for Non-inflammatory Lesions at Week 24 |
78; 43.3 | — |
| SECONDARY Investigator Global Assessment (IGA) Maintenance Success at Week 24 |
70.7; 34.2 | — |
| SECONDARY Percent of Subjects With Adverse Events |
41.5; 29.2 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who completed the previous study (RD.03.SPR29074 - NCT00688064)and had obtained at least a good Improvement (Grade, 0, 1, 2 or 3)
Exclusion Criteria
- Female Subjects who are pregnant, nursing or planning a pregnancy during the study
- Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc).
Data sourced from ClinicalTrials.gov (NCT00687908). 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.