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Anti-Infective Agent

A Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris

Phase 3
Waitlist Available
Research Sponsored by Almirall, S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial

Summary

This study will assess the safety and efficacy of dapsone gel versus vehicle control in patients with acne vulgaris.

Eligible Conditions
  • Acne Vulgaris
  • Acne

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 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 Inflammatory Facial Lesion Counts
Change From Baseline in Noninflammatory Facial Lesion Counts
Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS)
Secondary study objectives
Change From Baseline in Total Lesion Counts
Change From Baseline in the 9-Item ASIS Sign Domain Score
Percentage Change From Baseline in Total Lesion Counts
+3 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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dapsone GelExperimental Treatment1 Intervention
Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
Group II: Dapsone Gel VehiclePlacebo Group1 Intervention
Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily 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?

Almirall, S.A.Lead Sponsor
61 Previous Clinical Trials
16,144 Total Patients Enrolled
7 Trials studying Acne Vulgaris
5,415 Patients Enrolled for Acne Vulgaris
AllerganIndustry Sponsor
781 Previous Clinical Trials
274,583 Total Patients Enrolled
18 Trials studying Acne Vulgaris
6,677 Patients Enrolled for Acne Vulgaris
Medical DirectorStudy DirectorAllergan
2,900 Previous Clinical Trials
8,088,332 Total Patients Enrolled
10 Trials studying Acne Vulgaris
3,246 Patients Enrolled for Acne Vulgaris
~174 spots leftby Dec 2025
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