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

NCT ID: NCT02465632

Last Updated: 2017-06-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel

apply a thin layer of gel to the face

Group Type EXPERIMENTAL

Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel

Intervention Type DRUG

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

apply a thin layer of the gel to the face

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Placebo topical gel

apply a thin layer of the gel to the face

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel

Intervention Type DRUG

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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glenmark Pharmaceuticals Ltd. India

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mahesh V Deshpande

Role: STUDY_DIRECTOR

Glenmark Pharmaceuticals Ltd

Locations

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Glenmark Investigational Site 13

Anaheim, California, United States

Site Status

Glenmark Investigational Site 6

Long Beach, California, United States

Site Status

Glenmark Investigational Site 15

Los Angeles, California, United States

Site Status

Glenmark Investigational Site12

West Covina, California, United States

Site Status

Glenmark Investigational Site 4

Brandon, Florida, United States

Site Status

Glenmark Investigational Site 1

Miami, Florida, United States

Site Status

Glenmark Investigational Site 8

Miami, Florida, United States

Site Status

Glenmark Investigational Site 9

Miramar, Florida, United States

Site Status

Glenmark Investigational Site 2

St. Petersburg, Florida, United States

Site Status

Glenmark Investigational Site 5

Louisville, Kentucky, United States

Site Status

Glenmark Investigational Site7

Upper Saint Clair, Pennsylvania, United States

Site Status

Glenmark Investigational Site 14

Greenville, South Carolina, United States

Site Status

Glenmark Investigational Site 3

Nashville, Tennessee, United States

Site Status

Glenmark Investigational Site 10

Belize City, , Belize

Site Status

Glenmark Investigational Site 11

Belize City, , Belize

Site Status

Countries

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United States Belize

Other Identifiers

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GLK-1403

Identifier Type: -

Identifier Source: org_study_id

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