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

A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo Israel Pharmaceuticals, Ltd., Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to a Comparator Clindamycin / Benzoyl Peroxide Topical Gel, and Both Active Treatments to a Vehicle Control in the Treatment of Acne Vulgaris

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 Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Placebo; Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo); Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin)

• Study Type: Interventional
• Enrollment (Actual): 1555
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Vehicle	Drug: Placebo; Placebo
ACTIVE_COMPARATOR: Reference Product	Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin); Applied to the entire face twice daily for 10 weeks
ACTIVE_COMPARATOR: Clindamycin 1%/Benzoyl Peroxide 5%	Drug: Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo); Applied to the entire face twice daily for 10 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change From Baseline in Inflammatory Lesions	10 weeks
Percent Change From Baseline in Non-inflammatory Lesions	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 weeks

Collaborators and Investigators

• Sponsor: Padagis LLC

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ACTUAL): October 1, 2010
• Study Completion (ACTUAL): October 1, 2010

Study Registration Dates

• First Submitted: June 4, 2010
• First Submitted That Met QC Criteria: June 4, 2010
• First Posted (ESTIMATE): June 7, 2010

Study Record Updates

• Last Update Posted (ACTUAL): October 13, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Dermatologic Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
• Other Study ID Numbers: PRG-716