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

Padagis

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Placebo; Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo); Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01138514

PRG-716

Details and patient eligibility

About

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).

Enrollment: 1,555 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,555 participants in 3 patient groups, including a placebo group

Clindamycin 1%/Benzoyl Peroxide 5%

Active Comparator group

Treatment:

Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo)

Reference Product

Active Comparator group

Treatment:

Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin)

Vehicle

Placebo Comparator group

Treatment:

Drug: Placebo