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Trial record 4 of 16 for:    Belize

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

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ClinicalTrials.gov Identifier: NCT02465632
Recruitment Status : Completed
First Posted : June 8, 2015
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Glenmark Pharmaceuticals Ltd. India

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel Drug: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : April 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015


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



Primary Outcome Measures :
  1. Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules) [ Time Frame: Baseline and 10 Weeks ]
    The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated.

  2. Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones) [ Time Frame: Baseline and 10 Weeks ]
    The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated.



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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02465632


Locations
United States, California
Glenmark Investigational Site 13
Anaheim, California, United States
Glenmark Investigational Site 6
Long Beach, California, United States
Glenmark Investigational Site 15
Los Angeles, California, United States
Glenmark Investigational Site12
West Covina, California, United States
United States, Florida
Glenmark Investigational Site 4
Brandon, Florida, 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 2
Saint Petersburg, Florida, United States
United States, Kentucky
Glenmark Investigational Site 5
Louisville, Kentucky, United States
United States, Pennsylvania
Glenmark Investigational Site7
Upper Saint Clair, Pennsylvania, United States
United States, South Carolina
Glenmark Investigational Site 14
Greenville, South Carolina, United States
United States, Tennessee
Glenmark Investigational Site 3
Nashville, Tennessee, United States
Belize
Glenmark Investigational Site 10
Belize City, Belize
Glenmark Investigational Site 11
Belize City, Belize
Sponsors and Collaborators
Glenmark Pharmaceuticals Ltd. India
Investigators
Study Director: Mahesh V Deshpande Glenmark Pharmaceuticals Ltd

Responsible Party: Glenmark Pharmaceuticals Ltd. India
ClinicalTrials.gov Identifier: NCT02465632     History of Changes
Other Study ID Numbers: GLK-1403
First Posted: June 8, 2015    Key Record Dates
Results First Posted: June 28, 2017
Last Update Posted: June 28, 2017
Last Verified: December 2015

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Benzoyl Peroxide
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents