Phase 3
Completed N=459
Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris
Severe Acne Vulgaris
Source: ClinicalTrials.gov NCT00688064 ↗
Enrolled (actual)
459
Serious AEs
0.0%
Results posted
Mar 2010
Primary outcomePrimary: Percent Change From Baseline in Total Lesion Counts at Week 12. — -64; -41 % of change
Summary
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Total Lesion Counts at Week 12. |
-64; -41 | — |
| SECONDARY Percent Change From Baseline in Inflammatory Lesion Counts at Week 12. |
-72; -48 | — |
| SECONDARY Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12 |
-61; -40 | — |
| SECONDARY Success Rate on the Investigator's Global Assessment |
31.5; 8.4 | — |
| SECONDARY Percent of Subjects With Adverse Events |
26.3; 26.9 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female Subjects of any race, aged 12 to 35 years inclusive
- Subjects with severe facial acne (global severity score of 4)
- Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, excluding the nose
- Subjects with a minimum of 30 and a maximum of 120 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose
Exclusion Criteria
- Subjects with more than 3 nodules or cysts on the face,
- Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)
Data sourced from ClinicalTrials.gov (NCT00688064). 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.