Phase 4
N=163
Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT00835198 ↗Enrolled (actual)
163
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcome: Primary: Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12 — 38.96; 40.06; -24.05; -25.82 Number of Lesions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dapsone; Tretinoin (Drug); Tretinoin (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12 |
38.96; 40.06; -24.05; -25.82 | — |
| SECONDARY Change From Baseline in Investigator Global Assessment at Week 12 |
3.02; 2.99; -1.07; -1.08 | — |
| SECONDARY Change From Baseline in Overall Disease Severity at Week 12 |
4.14; 4.05; -1.79; -1.76 | — |
| SECONDARY Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12 |
40.94; 40.69; -19.91; -15.81 | — |
Summary
A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe facial acne vulgaris
Eligibility Criteria
Inclusion Criteria
- Facial acne vulgaris characterized by the following:
- 30-100 facial inflammatory lesions; and, 25-100 facial non-inflammatory lesions;
- Stable disease, non-rapidly regressing facial acne vulgaris; and, less than or equal to 3 nodules and/or cysts (diameter greater than or equal to 1cm)
- Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study
Exclusion Criteria
- Non-compliance with washout period;
- History of clinically significant anemia or hemolysis;
- Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris;
- Allergy or sensitivity to any component of the test medications
Data sourced from ClinicalTrials.gov (NCT00835198). 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.