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Anti-Infective Agent

Dapsone 5.0% Gel (SEEGPharm) for Acne

Phase 3
Waitlist Available
Research Sponsored by Seegpharm S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) to week 12 (day 85)
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial

Summary

Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) to week 12 (day 85)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) to week 12 (day 85) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Comparisons of Active Products: Mean percent change in the inflammatory lesion (papules and pustules) counts and non-inflammatory lesion (open and closed comedones) counts
Secondary study objectives
Clinical Success: Proportion of subjects with a clinical response of "success"
Other study objectives
Safety Outcomes: Change in Vital Signs
Safety Outcomes: Incidence of Adverse Events
Safety Outcomes: Local Skin/Application Site Reaction Scores

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

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Dapsone 5.0% Gel (SEEGPharm)Experimental Treatment1 Intervention
Dapsone 5.0% Gel applied twice daily for 84 days
Group II: Dapsone 5.0% Gel (Allergan)Active Control1 Intervention
Dapsone 5.0% Gel applied twice daily for 84 days
Group III: PlaceboPlacebo Group1 Intervention
Vehicle of Experimental Gel applied twice daily for 84 days
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?

Seegpharm S.A.Lead Sponsor
Karen Lewis, MSStudy DirectorCatawba Clinical Research
~244 spots leftby Oct 2025
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