A Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel in the Treatment of Acne Vulgaris

Phase 1

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Onexton™ Gel; Drug: Placebo; Drug: Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%

• Registration Number: NCT02578043
• Lead Sponsor: Taro Pharmaceuticals USA

Brief Summary

The objectives of this study are to evaluate the therapeutic equivalence and safety.

Detailed Description

The objectives of this study are to evaluate the therapeutic equivalence and safety of the test product Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to the reference product Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of these test and reference products over the placebo control.

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2015-08
• Study Completion: 2015-09
• Study First Submitted: 2015-10-14
• Study First Submitted QC: 2015-10-15
• Study First Posted: 2015-10-16
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-16
• Last Update Posted: 2018-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 844

Inclusion Criteria

• Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
• Must have a minimum ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
• Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.

Read More

Exclusion Criteria

• Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
• A history or presence of Crohn's disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis.
• A history of hypersensitivity or allergy to clindamycin, benzoyl peroxide and/or any of the study medication ingredients and its excipients.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Onexton™ Gel	Onexton™ Gel	Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) applied to the face once daily for 84 days.
Placebo	Placebo	Placebo (vehicle of the test product) applied to the face once daily for 84 days.
Clindamycin and BPO Gel 1.2%/3.75%	Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%	Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% applied to the face once daily for 84 days.

Primary Outcome Measures

Name	Time	Method
Demonstration of Bioequivalence	Week 12	Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts

Secondary Outcome Measures

Name	Time	Method
Clinical response of success	Week 12	The proportion of subjects with a clinical response of success at week 12 defined as an Investigator's Global Assessment score that is at least 2 grades less than the baseline assessment.