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

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.

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Placebo; Drug: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel; Drug: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%

• Study Type: Interventional
• Enrollment (Actual): 1100
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel; apply a thin layer of gel to the face	Drug: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
Active Comparator: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%; apply a thin layer of the gel to the face	Drug: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
Placebo Comparator: Placebo topical gel; apply a thin layer of the gel to the face	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Glenmark Pharmaceuticals Ltd. India
• Investigators: Study Director: Mahesh V Deshpande, Glenmark Pharmaceuticals Ltd

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 4, 2015
• First Submitted That Met QC Criteria: June 4, 2015
• First Posted (Estimate): June 8, 2015

Study Record Updates

• Last Update Posted (Actual): June 28, 2017
• Last Update Submitted That Met QC Criteria: May 26, 2017
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Dermatologic Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
• Other Study ID Numbers: GLK-1403