Phase 4
Completed N=68
A Study of Dapsone Gel in Females With Skin of Color and Acne Vulgaris
Source: ClinicalTrials.gov NCT02032407 ↗Enrolled (actual)
68
Serious AEs
1.5%
Results posted
Aug 2015
Primary outcomePrimary: Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician — 2.8; -1.2 score on a scale
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.
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 | — |
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. Informational only — not medical advice.