Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris
NCT ID: NCT02959970
Last Updated: 2020-03-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2016-10-31
2018-03-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PK Cohort: ACZONE 7.5%
Participants applied ACZONE 7.5 % gel topically, once-daily to the entire face, neck, upper chest, upper back and shoulders starting from Day 1 under maximal use conditions (2 grams per day) for Day 8 consecutive days, followed by a thin layer to their face and acne-affected areas on the upper chest, upper back, and shoulders for next 11 weeks.
dapsone gel
Dapsone (ACZONE) 7.5% gel topically once daily.
Non-PK Cohort: ACZONE 7.5%
Participants applied ACZONE 7.5% gel topically, once-daily in a thin layer to their face and acne-affected areas on upper chest, upper back, and shoulders for 12 weeks.
dapsone gel
Dapsone (ACZONE) 7.5% gel topically once daily.
Interventions
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dapsone gel
Dapsone (ACZONE) 7.5% gel topically once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Has severe cystic acne, acne conglobata, acne fulminans, or secondary acne (chloracne, drug-induced acne)
* Has used topical dapsone within 1 month prior to the screening
* Has used oral dapsone within 2 months prior to screening.
9 Years
11 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Almirall, S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Cathy Truong
Role: STUDY_DIRECTOR
Allergan
Locations
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Kirklin Clinic
Birmingham, Alabama, United States
Center for Dermatology Clinical Research
Fremont, California, United States
Quest Dermatology Research
Northridge, California, United States
Southern California Dermatology
Santa Ana, California, United States
Redwood Family Dermatology
Santa Rosa, California, United States
Center for Clinical and Cosmetic Research
Aventura, Florida, United States
Baumann Cosmetic and Research Institute
Miami Beach, Florida, United States
Dermresearch, PLLC
Louisville, Kentucky, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, United States
Saint Louis University Dermatology
St Louis, Missouri, United States
Skin Specialists, PC
Omaha, Nebraska, United States
Skin Specialty Dermatology
New York, New York, United States
Health Sciences/Department of Dermatology
Winston-Salem, North Carolina, United States
KGL Skin Study Center
Broomall, Pennsylvania, United States
Department of Dermatology, UPCII
Hershey, Pennsylvania, United States
Arlington Research Center, Inc.
Arlington, Texas, United States
DermResearch, LLC
Austin, Texas, United States
University of Texas Medical School at Houston
Houston, Texas, United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, United States
Premier Clinical Research
Spokane, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1679-401-006
Identifier Type: -
Identifier Source: org_study_id
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