Phase 4
N=68
A Study of Dapsone Gel in Females With Skin of Color and Acne Vulgaris
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT02032407 ↗Enrolled (actual)
68
Serious AEs
1.5%
Results posted
Aug 2015
Primary outcome: Primary: Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician — 2.8; -1.2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dapsone Gel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Allergan
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician |
2.8; -1.2 | — |
| SECONDARY Change From Baseline in the GAAS |
2.8; -0.3; -0.6 | — |
| SECONDARY Percent Change From Baseline in Total Lesion Counts |
-16.0; -30.0; -52.0 | — |
| SECONDARY Percent Change From Baseline in Inflammatory Lesion Counts |
-25.0; -48.0; -65.0 | — |
| SECONDARY Percent Change From Baseline in Non-Inflammatory Lesion Counts |
-9.8; -16.0; -41.0 | — |
| SECONDARY Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS |
6.0; 13.1; 42.9 | — |
| SECONDARY Acne Symptom and Impact Scale (ASIS) Sign Domain Score |
1.7; 1.3; 1.1 | — |
| SECONDARY ASIS Impact Domain Score |
1.6; 1.3; 1.1 | — |
Summary
This study will evaluate the effect of dapsone gel in female subjects with skin of color (Fitzpatrick Skin Types IV, V, and VI) with acne vulgaris.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of acne vulgaris
- Medium to dark complexion (Fitzpatrick Skin Type IV, V or VI)
- Willing to avoid excessive or prolonged exposure of the face to ultraviolet light (eg, sunlight, tanning beds) throughout the study
Exclusion Criteria
- Received treatment with botulinum toxin of any serotype in the face within 6 months
Data sourced from ClinicalTrials.gov (NCT02032407). 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.