A Study of Dapsone Gel in Females With Skin of Color and Acne Vulgaris
1 other identifier
interventional
68
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2013
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 8, 2014
CompletedFirst Posted
Study publicly available on registry
January 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
August 19, 2015
CompletedAugust 19, 2015
August 1, 2015
6 months
January 8, 2014
June 15, 2015
August 11, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician
The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement.
Baseline, Week 12
Secondary Outcomes (7)
Change From Baseline in the GAAS
Baseline, Weeks 2 and 6
Percent Change From Baseline in Total Lesion Counts
Baseline, Weeks 2, 6 and 12
Percent Change From Baseline in Inflammatory Lesion Counts
Baseline, Weeks 2, 6 and 12
Percent Change From Baseline in Non-Inflammatory Lesion Counts
Baseline, Weeks 2, 6 and 12
Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS
Weeks 2, 6 and 12
- +2 more secondary outcomes
Study Arms (1)
Dapsone Gel
EXPERIMENTALDapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Interventions
Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Received treatment with botulinum toxin of any serotype in the face within 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (1)
Unknown Facility
Washington D.C., District of Columbia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President Medical Affairs,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2014
First Posted
January 10, 2014
Study Start
December 1, 2013
Primary Completion
June 1, 2014
Study Completion
September 1, 2014
Last Updated
August 19, 2015
Results First Posted
August 19, 2015
Record last verified: 2015-08