Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris

Taro Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: Adapalene/BP gel, 0.3%/2.5%; Drug: EPIDUO® FORTE; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02709902

ADBG 1519

Details and patient eligibility

About

Bioequivalence with Clinical Endpoints.

Full description

Randomized, Double-Blind, Placebo-Controlled, Multiple-Site, Parallel Design, Bioequivalence with Clinical Endpoints.

Enrollment: 460 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy male or non pregnant female aged ≥ 12 and ≤ 40years with a clinical diagnosis of acne vulgaris.

Exclusion criteria

• Female Subjects who are pregnant, nursing or planning to become pregnant during study participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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460 participants in 3 patient groups, including a placebo group

Adapalene/BP gel, 0.3%/2.5%

Experimental group

Description:

Topical, once daily, for 84 days.

Treatment:

Drug: Adapalene/BP gel, 0.3%/2.5%

EPIDUO® FORTE

Active Comparator group

Description:

Topical, once daily, for 84 days.

Treatment:

Drug: EPIDUO® FORTE

Placebo

Placebo Comparator group

Description:

Topical, once daily, for 84 days.

Treatment:

Drug: Placebo