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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02578043
• Other study ID #: CLBG 1508
• Status: Completed
• Phase: Phase 1
• Start date: April 2015
• Est. completion date: September 2015

Study information

• Verified date: May 2018
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 844
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%
Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% (Taro Pharmaceuticals Inc.)
• Onexton™ Gel
Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) (Valeant Pharmaceuticals LLC)
• Placebo
Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstration of Bioequivalence	Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts	Week 12
Secondary	Clinical response of success	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.	Week 12