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

• Status: Completed
• Trial end date: 2018-03-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan; Almirall, S.A.
• Collaborator: Allergan
• Treatments: Dapsone

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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.