A Study of Dapsone Gel in Females With Skin of Color and Acne Vulgaris

Condition(s) targeted: Acne Vulgaris

Intervention: Dapsone Gel (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan

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.

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician

Secondary outcome:

Change From Baseline in the GAAS

Percent Change From Baseline in Total Lesion Counts

Percent Change From Baseline in Inflammatory Lesion Counts

Percent Change From Baseline in Non-Inflammatory Lesion Counts

Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS

Acne Symptom and Impact Scale (ASIS) Sign Domain Score

ASIS Impact Domain Score

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Washington, District of Columbia, United States

Starting date: December 2013
Last updated: August 11, 2015