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Anti-Infective Agent

Dapsone Gel for Acne Vulgaris

Phase 4
Waitlist Available
Research Sponsored by Allergan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 2, 6 and 12
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

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.

Eligible Conditions
  • Acne Vulgaris
  • Acne

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 2, 6 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 2, 6 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician
Secondary study objectives
ASIS Impact Domain Score
Acne Symptom and Impact Scale (ASIS) Sign Domain Score
Change From Baseline in the GAAS
+4 more

Side effects data

From 2014 Phase 4 trial • 68 Patients • NCT02032407
1%
Spontaneous abortion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dapsone Gel

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dapsone GelExperimental Treatment1 Intervention
Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapsone
FDA approved

Find a Location

Who is running the clinical trial?

AllerganLead Sponsor
781 Previous Clinical Trials
276,586 Total Patients Enrolled
18 Trials studying Acne Vulgaris
8,711 Patients Enrolled for Acne Vulgaris
Medical DirectorStudy DirectorAllergan
2,887 Previous Clinical Trials
8,088,964 Total Patients Enrolled
10 Trials studying Acne Vulgaris
5,280 Patients Enrolled for Acne Vulgaris
~6 spots leftby Nov 2025
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