Phase 3
N=459
Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris
Severe Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT00688064 ↗Enrolled (actual)
459
Serious AEs
0.0%
Results posted
Mar 2010
Primary outcome: Primary: Percent Change From Baseline in Total Lesion Counts at Week 12. — -64; -41 % of change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Adapalene BPO Gel associated with Doxycyline Hyclate (Drug); Vehicle Gel associated with Doxycycline Hyclate (Drug)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Feb 2009
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 | — |
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.
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.