Trial of Dapsone 5.0% Gel in the Treatment of Acne Vulgaris
NCT ID: NCT02865005
Last Updated: 2016-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2361 participants
INTERVENTIONAL
2016-02-29
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dapsone 5.0% Gel (Allergan)
Dapsone 5.0% Gel applied twice daily for 84 days
Dapsone 5.0% Gel (Allergan)
Topical Gel
Dapsone 5.0% Gel (SEEGPharm)
Dapsone 5.0% Gel applied twice daily for 84 days
Dapsone 5.0% Gel (SEEGPharm)
Topical Gel
Placebo
Vehicle of Experimental Gel applied twice daily for 84 days
Placebo
Topical Gel
Interventions
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Dapsone 5.0% Gel (SEEGPharm)
Topical Gel
Placebo
Topical Gel
Dapsone 5.0% Gel (Allergan)
Topical Gel
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed Consent/Assent: For subjects 12 to 17 years of age inclusive must have provided Institutional Review Board (IRB) approved written assent that must be accompanied by an IRB approved written consent from the subject's legally acceptable representatives (i.e., parent or guardian). In addition, all subjects or their legally acceptable representatives must sign a Health Insurance Portability and Accountability Act (HIPAA) authorization.
* On the face, subjects must have ≥ 20 inflammatory lesions (i.e., papules and pustules), AND ≥ 25 non-inflammatory lesions (open and closed comedones) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts). For the purposes of study treatment and evaluation, all lesions on the face should be counted, including those on the nose. Subjects may have acne lesions on other areas of the body (e.g., back, chest, and arms) which should be excluded from the count, treatment and the IGA evaluation.
* Subjects must have an acne severity grade of 3 or 4 per the IGA
* Subjects must be willing to refrain from using all other topical acne medications or antibiotics during the 12-week treatment period other than the study drug.
Exclusion Criteria
* Prior or current concomitant therapies skin conditions that would interfere with assessments in the study.
* Prior, current or planned procedures that would interfere with assessments in the study.
* Current or planned activities that would interfere with assessment in the study.
* Subjects who have a Baseline local skin site reaction score of 3 \[severe (marked/intense)\] for any signs and/or symptoms of irritation as scored using the local skin site reaction scores.
12 Years
40 Years
ALL
No
Sponsors
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Seegpharm S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Karen Lewis, MS
Role: STUDY_DIRECTOR
Catawba Clinical Research
Locations
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Catawba Clinical Research
Encino, California, United States
Catawba Clinical Research
Fullerton, California, United States
Catawba Clinical Research
La Mesa, California, United States
Catawba Clinical Research
Los Angeles, California, United States
Catawba Clinical Research
Los Angeles, California, United States
Catawba Clinical Research
Sherman Oaks, California, United States
Catawba Clinical Research
Temecula, California, United States
Catawba Clinical Research
Boca Raton, Florida, United States
Catawba Clinical Research
Brandon, Florida, United States
Catawba Clinical Research
Hialeah, Florida, United States
Catawba Clinical Research
Miami, Florida, United States
Catawba Clinical Research
Miramar, Florida, United States
Catawba Clinical Research
South Tampa, Florida, United States
Catawba Clinical Research
Tampa, Florida, United States
Catawba Clinical Research
Savannah, Georgia, United States
Catawba Clinical Research
New Orleans, Louisiana, United States
Catawba Clinical Research
Norfolk, Nebraska, United States
Catawba Clinical Research
Omaha, Nebraska, United States
Catawba Clinical Research
Las Vegas, Nevada, United States
Catawba Clinical Research
Las Vegas, Nevada, United States
Catawba Clinical Research
Las Vegas, Nevada, United States
Catawba Clinical Research
Endwell, New York, United States
Catawba Clinical Research
New York, New York, United States
Catawba Clinical Research
High Point, North Carolina, United States
Catawba Clinical Research
Wilmington, North Carolina, United States
Catawba Clinical Research
Cincinnati, Ohio, United States
Catawba Clinical Research
Jenkintown, Pennsylvania, United States
Catawba Clinical Research
Upper Saint Clair, Pennsylvania, United States
Catawba Clinical Research
Warminster, Pennsylvania, United States
Catawba Clinical Research
Nashville, Tennessee, United States
Catawba Clinical Research
Austin, Texas, United States
Catawba Clinical Research
El Paso, Texas, United States
Catawba Clinical Research
Mesquite, Texas, United States
Catawba Clinical Research
Norfolk, Virginia, United States
Catawba Clinical Research
Richland, Washington, United States
Catawba Clinical Research
Belize City, , Belize
Countries
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Other Identifiers
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SEEG-2015-6-23
Identifier Type: -
Identifier Source: org_study_id