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

NCT02578043 | Completed Phase 1

• 1 other identifier: CLBG 1508
• Study Type: interventional
• Target: 844
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Demonstration of Bioequivalence

  Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts

  Week 12

Secondary Outcomes (1)

• Clinical response of success

  Week 12

Study Arms (3)

Clindamycin and BPO Gel 1.2%/3.75%

EXPERIMENTAL

Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% applied to the face once daily for 84 days.

Drug: Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%

Onexton™ Gel

ACTIVE COMPARATOR

Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) applied to the face once daily for 84 days.

Drug: Onexton™ Gel

Placebo

PLACEBO COMPARATOR

Placebo (vehicle of the test product) applied to the face once daily for 84 days.

Drug: Placebo

Interventions

Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% DRUG

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

Also known as: Clindamycin, BPO

Clindamycin and BPO Gel 1.2%/3.75%

Onexton™ Gel DRUG

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

Also known as: Clindamycin, BPO

Onexton™ Gel

Placebo DRUG

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

Also known as: Vehicle

Placebo

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Clindamycin

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Catawba Research

  http://catawbaresearch.com/contact/

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 16, 2015
• Study Start: April 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 18, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share