Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris

Completed · Phase 4

Conditions studied: Acne Vulgaris

In brief

This study will evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of ACZONE Gel, 7.5% administered topically once-daily for 12 weeks in 9 to 11 year-olds with acne vulgaris.

Key facts

Study ID

NCT02959970

Run by

Almirall, S.A.

People needed

100

Starts

2016-10-31

Expected to finish

2018-03-09

Last updated by the study team

2020-03-03

Who can join

Age: 9 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has acne vulgaris on the face, including the nose, with 20 to 100 total lesions (noninflammatory and/or inflammatory).

You may not qualify if…

• Has uncontrolled systemic disease(s)
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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