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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
Placebo
Sponsored by
Glenmark Pharmaceuticals Ltd. India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Glenmark Investigational Site 13
  • Glenmark Investigational Site 6
  • Glenmark Investigational Site 15
  • Glenmark Investigational Site12
  • Glenmark Investigational Site 4
  • Glenmark Investigational Site 1
  • Glenmark Investigational Site 8
  • Glenmark Investigational Site 9
  • Glenmark Investigational Site 2
  • Glenmark Investigational Site 5
  • Glenmark Investigational Site7
  • Glenmark Investigational Site 14
  • Glenmark Investigational Site 3
  • Glenmark Investigational Site 10
  • Glenmark Investigational Site 11

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel

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

Placebo topical gel

Arm Description

apply a thin layer of gel to the face

apply a thin layer of the gel to the face

apply a thin layer of the gel to the face

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 4, 2015
Last Updated
May 26, 2017
Sponsor
Glenmark Pharmaceuticals Ltd. India
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1. Study Identification

Unique Protocol Identification Number
NCT02465632
Brief Title
To Study Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) in the Treatment of Acne Vulgaris.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glenmark Pharmaceuticals Ltd. India

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
Arm Type
Experimental
Arm Description
apply a thin layer of gel to the face
Arm Title
BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
Arm Type
Active Comparator
Arm Description
apply a thin layer of the gel to the face
Arm Title
Placebo topical gel
Arm Type
Placebo Comparator
Arm Description
apply a thin layer of the gel to the face
Intervention Type
Drug
Intervention Name(s)
Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
Intervention Type
Drug
Intervention Name(s)
BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)
Description
The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated.
Time Frame
Baseline and 10 Weeks
Title
Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones)
Description
The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated.
Time Frame
Baseline and 10 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahesh V Deshpande
Organizational Affiliation
Glenmark Pharmaceuticals Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Glenmark Investigational Site 13
City
Anaheim
State/Province
California
Country
United States
Facility Name
Glenmark Investigational Site 6
City
Long Beach
State/Province
California
Country
United States
Facility Name
Glenmark Investigational Site 15
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Glenmark Investigational Site12
City
West Covina
State/Province
California
Country
United States
Facility Name
Glenmark Investigational Site 4
City
Brandon
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 1
City
Miami
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 8
City
Miami
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 9
City
Miramar
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 2
City
Saint Petersburg
State/Province
Florida
Country
United States
Facility Name
Glenmark Investigational Site 5
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Glenmark Investigational Site7
City
Upper Saint Clair
State/Province
Pennsylvania
Country
United States
Facility Name
Glenmark Investigational Site 14
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
Glenmark Investigational Site 3
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Glenmark Investigational Site 10
City
Belize City
Country
Belize
Facility Name
Glenmark Investigational Site 11
City
Belize City
Country
Belize

12. IPD Sharing Statement

Learn more about this trial

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

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