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

A Multi Center Double Blind Randomized Placebo Controlled Parallel Group Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02578043

Enrollment

844

Registered

2015-10-16

Start date

2015-04-30

Completion date

2015-09-30

Last updated

2018-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

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.

Interventions

DRUGClindamycin and Benzoyl Peroxide Gel 1.2%/3.75%

Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% (Taro Pharmaceuticals Inc.)

DRUGOnexton™ Gel

Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) (Valeant Pharmaceuticals LLC)

DRUGPlacebo

Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to 40 Years

Healthy volunteers

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.

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.

Design outcomes

Primary

Measure	Time frame	Description
Demonstration of Bioequivalence	Week 12	Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts

Secondary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026