To Study Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) in the Treatment of Acne Vulgaris.

Acne Vulgaris Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) to the Marketed Product BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% (Valeant Pharmaceuticals, US) in the Treatment of Acne Vulgaris.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465632
• Other study ID #: GLK-1403
• Status: Completed
• Phase: Phase 3
• First received: June 4, 2015
• Last updated: December 11, 2015
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Glenmark Pharmaceuticals Ltd. India
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1%/ Benzoyl peroxide 5% topical gel (Glenmark Generics, Ltd), and the marketed product BenzaClin® Topical Gel, Clindamycin 1%/ Benzoyl peroxide 5% (Valeant Pharmaceuticals, US) in the treatment of acne vulgaris.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Male or non-pregnant, non-lactating female, =12 and =40 years of age with a clinical diagnosis of acne vulgaris.

2. Have facial acne with: =20 facial inflammatory lesions (papules and pustules) and =25 non-inflammatory lesions (open and closed comedones), and =2 nodulocystic lesions (nodules and cysts) and have an IGA score of 2, 3 or 4.

Exclusion Criteria:

1. Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.

2. Subject has active cystic acne.

3. Subject has acne conglobata.

4. Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel

• BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%

• Placebo

Locations

Country	Name	City	State
United States	Glenmark Investigational Site 13	Anaheim	California
United States	Glenmark Investigational Site 10	Belize City	Florida
United States	Glenmark Investigational Site 11	Belize City	Florida
United States	Glenmark Investigational Site 4	Brandon	Florida
United States	Glenmark Investigational Site 14	Greenville	South Carolina
United States	Glenmark Investigational Site 6	Long Beach	California
United States	Glenmark Investigational Site 15	Los Angeles	California
United States	Glenmark Investigational Site 5	Louisville	Kentucky
United States	Glenmark Investigational Site 1	Miami	Florida
United States	Glenmark Investigational Site 8	Miami	Florida
United States	Glenmark Investigational Site 9	Miramar	Florida
United States	Glenmark Investigational Site 3	Nashville	Tennessee
United States	Glenmark Investigational Site 2	St. Petersburg	Florida
United States	Glenmark Investigational Site7	Upper St. Clair	Pennsylvania
United States	Glenmark Investigational Site12	West Covina	California

Sponsors (1)

Lead Sponsor	Collaborator
Glenmark Pharmaceuticals Ltd. India

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean percent reduction from baseline to Week 10 in the number of inflamed lesions (papules/pustules)		10 weeks	No
Primary	Mean percent reduction from baseline to Week 10 in the number of non-inflamed lesions (open and closed comedones)		10 weeks	No
Secondary	Proportion of subjects considered to be a "Clinical Success" using the dichotomized IGA		10 weeks	No