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Anti-Infective Agent
Trial of Dapsone 5.0% Gel in the Treatment of Acne Vulgaris
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.
Eligible Conditions
- Acne Vulgaris
- Acne
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1) to week 12 (day 85)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) to week 12 (day 85)
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
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