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

NCT02465632 | Completed Phase 3 Results

• 1 other identifier: GLK-1403
• Study Type: interventional
• Target: 1,100
• Locations: 2 countries
• Sites: 15

Brief 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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)

  The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated.

  Baseline and 10 Weeks

• Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones)

  The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated.

  Baseline and 10 Weeks

Study Arms (3)

Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel

EXPERIMENTAL

apply a thin layer of gel to the face

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

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

ACTIVE COMPARATOR

apply a thin layer of the gel to the face

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

Placebo topical gel

PLACEBO COMPARATOR

apply a thin layer of the gel to the face

Drug: Placebo

Interventions

Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel DRUG

Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel

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

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

Placebo DRUG

Placebo topical gel

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.
• Subject has active cystic acne.
• Subject has acne conglobata.
• Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.

Sponsors & Collaborators

• Glenmark Pharmaceuticals Ltd. India: lead

Study Sites (15)

Glenmark Investigational Site 13

Anaheim, California, United States

Location

Glenmark Investigational Site 6

Long Beach, California, United States

Location

Glenmark Investigational Site 15

Los Angeles, California, United States

Location

Glenmark Investigational Site12

West Covina, California, United States

Location

Glenmark Investigational Site 4

Brandon, Florida, United States

Location

Glenmark Investigational Site 1

Miami, Florida, United States

Location

Glenmark Investigational Site 8

Miami, Florida, United States

Location

Glenmark Investigational Site 9

Miramar, Florida, United States

Location

Glenmark Investigational Site 2

St. Petersburg, Florida, United States

Location

Glenmark Investigational Site 5

Louisville, Kentucky, United States

Location

Glenmark Investigational Site7

Upper Saint Clair, Pennsylvania, United States

Location

Glenmark Investigational Site 14

Greenville, South Carolina, United States

Location

Glenmark Investigational Site 3

Nashville, Tennessee, United States

Location

Glenmark Investigational Site 10

Belize City, Belize

Location

Glenmark Investigational Site 11

Belize City, Belize

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Clindamycin; Benzoyl Peroxide; Gels

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; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Cathy Tyrrell
• Organization: Glenmark Pharmaceuticals Ltd

clinicaltrialsdisclosuredesk@glenmarkpharma.com

91 2267720000

Study Officials

• Mahesh V Deshpande

  Glenmark Pharmaceuticals Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: June 8, 2015
• Study Start: April 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 28, 2017
• Results First Posted: June 28, 2017

Record last verified: 2015-12

Locations

BE (2); US (13)