Phase 3
Completed N=1,670
A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
Source: ClinicalTrials.gov NCT00421993 ↗Enrolled (actual)
1,670
Serious AEs
0.4%
Results posted
Mar 2009
Primary outcomePrimary: Success Rate on the Investigator's Global Assessment — 37.9; 21.8; 26.7; 17.9 Percentage of participants
Summary
This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study.
The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success Rate on the Investigator's Global Assessment |
37.9; 21.8; 26.7; 17.9 | — |
| PRIMARY Changes in Inflammatory Lesion Counts |
-18; -15; -16; -12 | — |
| PRIMARY Changes in Noninflammatory Lesion Counts |
-28; -24; -23; -18 | — |
| SECONDARY Percent Change in Inflammatory Lesion Counts |
-61.7; -50.1; -52.2; -40.8 | — |
| SECONDARY Percent Change in Noniflammatory Lesion Counts |
-55.6; -46.0; -44.1; -32.3 | — |
| SECONDARY Percent Change in Total Lesion Counts |
-57.7; -47.5; -47.2; -35.2 | — |
Eligibility Criteria
Inclusion Criteria
- A clinical diagnosis of acne vulgaris with facial involvement.
- A minimum of 20 but not more than 50 Inflammatory lesions
- A minimum of 30 but not more than 100 Noninflammatory lesions
- A score of 3 (Moderate) on the Investigator's Global Assessment Scale.
Exclusion Criteria
- More than one acne nodule or any acne cyst.
- Acne conglobata, acne fulminans, secondary acne, or severe acne.
- Known previous participation in an Adapalene/Benzoyl Peroxide Topical Gel Trial.
- Underlying diseases that require the use of interfering topical or systemic therapy.
- Use of prohibited medications prior to the study unless appropriate washout period is documented
- Use of hormonal contraceptives solely for control of acne
Data sourced from ClinicalTrials.gov (NCT00421993). 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.