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

Information source: Allergan
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

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.

Clinical Details

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.


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

Locations and Contacts

Washington, District of Columbia, United States
Additional Information

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

Page last updated: August 20, 2015

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