A Phase 3 interventional study of Dapsone 5.0% Gel (SEEGPharm) and Placebo in Acne Vulgaris, sponsored by Seegpharm S.A.. Completed at 36 sites in 2 countries. Open to participants aged 12 Years to 40 Years. Per ClinicalTrials.gov, last updated 2016-12-20.
Sponsored by Seegpharm S.A. · Phase 3, Interventional, and Treatment
Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris.
Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris for 84 days in male and female subjects age 12-40.
790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.
This study's enrollment of 2,361 is above the median of 70 across 672 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →This is the only study on the registry with Seegpharm S.A. as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dapsone 5.0% Gel applied twice daily for 84 days
Drug: Dapsone 5.0% Gel (Allergan)
Dapsone 5.0% Gel applied twice daily for 84 days
Drug: Dapsone 5.0% Gel (SEEGPharm)
Vehicle of Experimental Gel applied twice daily for 84 days
Other: Placebo
Topical Gel
Also known as: Experimental Arm
Topical Gel
Also known as: Placebo Comparator
Topical Gel
Also known as: Active Comparator
Comparisons of Active Products: Mean percent change in the inflammatory lesion (papules and pustules) counts and non-inflammatory lesion (open and closed comedones) counts
To compare Dapsone 5% Gel (SEEGPharm) to Aczone® (Allergan's Dapsone 5% Gel) to the Placebo-Vehicle control with respect to the mean percent change in the inflammatory lesion (papules and pustules) counts and non-inflammatory lesion (open and closed comedones) counts, from Baseline (Visit 1/ Day1) to End-of-Treatment (EOT)
Time frame: Treatment Days: 84 days of dosing
Clinical Success: Proportion of subjects with a clinical response of "success"
To evaluate as the proportion of subjects with a clinical response of "success" at Week 12.
Time frame: 12 Weeks
Safety Outcomes: Incidence of Adverse Events
Analysis of the incidence of Adverse Events from Baseline (Day 1) to Week 12 (Day 85)
Time frame: Baseline (Day 1) to Week 12 (Day 85)
Safety Outcomes: Change in Vital Signs
Clinically Significant Changes in Body temperature (oral), pulse rate (sitting), blood pressure (sitting systolic and diastolic) from Baseline (Day 1) to Week 12 (Day 85)
Time frame: Baseline (Day 1) to Week 12 (Day 85)
Safety Outcomes: Local Skin/Application Site Reaction Scores
Application (local skin) sites will be assessed at each visit and scored using the local skin site reaction scores (0=Absent, 1=Mild, 2=Moderate, 3=Severe) for the following signs and symptoms of irritation: erythema, dryness, burning/stinging, erosion, edema, pain, and itching, for comparisons between groups.
Time frame: Baseline (Day 1) to Week 12 (Day 85)
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Feb 2016, a primary completion of Nov 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dapsone