Phase 4
Completed N=285
Epiduo Pediatric Acne Study
Source: ClinicalTrials.gov NCT01138735 ↗Enrolled (actual)
285
Serious AEs
0.4%
Results posted
Mar 2013
Primary outcomePrimary: Success Rate — 47.2; 15.4 percentage of participant — p=<0.001
Summary
The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 years of age with acne vulgaris.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success Rate |
47.2; 15.4 | <0.001 sig |
| PRIMARY Change From Baseline in Total Lesion Counts |
-27.6; -3.6 | <0.001 sig |
| SECONDARY Percent Change in Total Lesion Counts From Baseline |
-55.5; -9.3 | <0.001 sig |
| SECONDARY Change in Inflammatory Lesion Counts From Baseline |
-7.4; -0.7 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of acne vulgaris with facial involvement
- Score of 3 (moderate) on the Investigator's Global Assessment (IGA) scale
- A minimum of 20 but not more than 100 total lesions (Noninflammatory and/or Inflammatory) on the face (including the nose) at Baseline
Exclusion Criteria
- Acne nodule or acne cyst
- Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment
- Underlying diseases and/or dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments
- Use of prohibited medications prior to the study and/or are unwilling to refrain from such use during the study
Data sourced from ClinicalTrials.gov (NCT01138735). 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.