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

Padagis LLC1,555 enrolled

Overview

The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel (Clindamycin- Benzoyl Peroxide Gel).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,555

Conditions

Acne Vulgaris

Interventions

Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo)DRUG

Applied to the entire face twice daily for 10 weeks

Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin)DRUG

Applied to the entire face twice daily for 10 weeks

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 12 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy men or women, 12 to 65 years of age * Willing to participate and sign provide written consent * Moderate to severe acne Exclusion Criteria: * Pregnant or lactating women * History of unresponsiveness or hypersensitivity to clindamycin, benzoyl peroxide or lincomycin * Use of systemic, topical or facial products which may interfere with the study * Participation in any clinical study in the 30 days prior to study entry * Prolonged exposure to sunlight or excessive exposure to UV lights * Chronic use of NSAIDS

Outcomes

Primary Outcomes

Percent Change From Baseline in Inflammatory Lesions

Time frame: 10 weeks

Percent Change From Baseline in Non-inflammatory Lesions

Time frame: 10 weeks

Secondary Outcomes

Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA)

Clinical success was defined as a score of clear (0) or almost clear (1) at Week 10.

Time frame: 10 weeks

Data from ClinicalTrials.gov

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