Clinical Study Between Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations

Padagis

Status: Completed

Conditions: Acne Vulgaris

Treatments: Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01044264

DAC-501-601-727998

Details and patient eligibility

About

A randomized, double-blind, multiple-site, placebo-controlled, parallel-group clinical study conducted to evaluate the bioequivalence of two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel formulations.

Enrollment: 602 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy men or women, 12 years of age and older
• willing to participate and sign a copy of the informed consent form
• moderate to severe facial acne

Exclusion criteria

• history of allergy or hypersensitivity to clindamycin or benzoyl peroxide
• pregnant or lactating women
• evidence of a clinically significant disorder
• receipt of any drugs as part of a research study within 30 days prior to study dosing
• use of systemic, topical or facial products which may interfere with study
• significant facial hair, tattoos, excessive facial scarring, active facial sunburn, or peeling due to sunburn

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

602 participants in 3 patient groups, including a placebo group

1% Clindamycin/5% Benzoyl Peroxide Topical Gel

Active Comparator group

Description:

Test product

Treatment:

Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel

DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel

Active Comparator group

Description:

Reference product

Treatment:

Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo