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

Almirall

Status and phase: Completed; Phase 4

Conditions: Acne Vulgaris

Treatments: Drug: dapsone gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02959970

1679-401-006

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 9 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

PK Cohort: ACZONE 7.5%

Experimental group

Description:

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.

Treatment:

Drug: dapsone gel

Non-PK Cohort: ACZONE 7.5%

Experimental group

Description:

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.

Treatment:

Drug: dapsone gel