Phase 4
N=30
Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT01209949 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcome: Primary: Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12 — 18 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Adapalene 0.1% and Benzoyl Peroxide 2.5% gel (Drug)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12 |
18 | — |
| SECONDARY Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12. |
-44.1; -57.1; -49.7 | — |
| SECONDARY Number of Participants With Tolerability Assessments Resulting in an Adverse Event |
2 | — |
Summary
The purpose of this study is to assess subjects' experiences using Adapalene BPO gel to treat mild to moderate acne vulgaris using efficacy measurements, quality of life instruments, and video diaries.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects, aged 16 to 25 years inclusive;
- Subjects with mild or moderate facial acne (Investigator's Global Assessment (IGA) = 2 or 3;
- A minimum of 10 inflammatory lesions (papules and pustules) on the face (excluding the nose);
- Subjects who agree to be photographed at each visit;
- Subjects who agree to be video recorded by study designated staff members. They should be able to clearly and comfortably communicate their responses to questions and express their thoughts related to their disease and treatment throughout the study
Exclusion Criteria
- Subjects with nodules, cysts, acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.) or severe acne requiring systemic treatment;
- Subjects with a wash-out period for topical acne treatment on the face less than 30 days
- Subjects with a wash-out period for systemic acne treatment less than 30 days with the exception of isotretinoin which requires a washout of 4 months;
- Subjects who are currently being treated with antibiotics;
- Subjects who foresee intensive ultraviolet (UV) exposure during the study (mountain sports, UV radiation, sunbathing, tanning beds, etc.);
- Subjects who refuse photographic and videography procedures and/or refuse to sign a full release for their use in promotional materials
Data sourced from ClinicalTrials.gov (NCT01209949). 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.