Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

Taro Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: Clindamycin Phosphate; Drug: Clindamycin Phosphate RLD; Drug: Placebos

Study type: Interventional

Funder types: Industry

Identifiers

NCT04321070

CLPL 1907

Details and patient eligibility

About

Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

Full description

Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris

Enrollment: 550 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.
• Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent.
• Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).

Exclusion criteria

• Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
• Subjects with a history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients, have a known hypersensitivity to adapalene and benzoyl peroxide and its excitements.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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550 participants in 3 patient groups, including a placebo group

Clindamycin Phosphate

Experimental group

Description:

Topical, once daily, for 84 days.

Treatment:

Drug: Clindamycin Phosphate

Clindamycin Phosphate RLD

Active Comparator group

Description:

Topical, once daily, for 84 days

Treatment:

Drug: Clindamycin Phosphate RLD

Vehicle of the test product

Placebo Comparator group

Description:

Topical, once daily, for 84 days

Treatment:

Drug: Placebos