Phase 3
N=452
Long-term Study of Efficacy/Safety of Adapalene/Benzoyl Peroxide Topical Gel in Acne Vulgaris Subjects
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT00446043 ↗Enrolled (actual)
452
Serious AEs
1.1%
Results posted
Jul 2023
Primary outcome: Primary: Percent Change From Baseline in Inflammatory, Noninflammatory and Total Lesion Count at Month 12 LOCF — -59.70; -58.80; -58.85 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Adapalene/Benzoyl Peroxide (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- May 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Inflammatory, Noninflammatory and Total Lesion Count at Month 12 LOCF |
-59.70; -58.80; -58.85 | — |
| PRIMARY Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 6 |
17; 149; 147; 31; 11; 4 | — |
| PRIMARY Number of Participants Categorized Based on Participant's Assessment Scale of Acne at Month 12 |
40; 164; 77; 37; 6; 3 | — |
| SECONDARY Number of Participants With Local Tolerability Assessment For Erythema |
348; 94; 10; 0; 233; 157 | — |
| SECONDARY Number of Participants With Local Tolerability Assessment For Scaling |
410; 41; 1; 0; 228; 164 | — |
| SECONDARY Number of Participants With Local Tolerability Assessment For Dryness |
385; 65; 2; 0; 195; 190 | — |
| SECONDARY Number of Participants With Local Tolerability Assessment For Stinging/Burning |
440; 10; 2; 0; 201; 154 | — |
| SECONDARY Number of Participant With Adverse Event (AE) and Serious Adverse Event (SAE) |
288; 5 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormal Laboratory Parameters |
0; 0; 0 | — |
Summary
This was a multi-center, open-label, non-comparative study that evaluated the long-term safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel.
Subjects were evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12.
Safety was evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing (hematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations. Efficacy was evaluated by analysis of Percent Change from Baseline in Inflammatory, Noninflammatory, and Total Lesion Counts, and by the Subject's Assessment of Acne.
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.
Exclusion Criteria
- Subjects with presence of nodules or cysts.
- Acne conglobate, acne fulminans, secondary acne, or severe acne.
- Underlying diseases that required the use of interfering topical or systemic therapy.
- Use of prohibited medications prior to the study unless appropriate washout period was documented.
Data sourced from ClinicalTrials.gov (NCT00446043). 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.