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Trial record 47 of 231 for:    clindamycin

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
Drug: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
Drug: Placebo
Enrollment 1100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% Placebo Topical Gel
Hide Arm/Group Description Test: A thin layer of gel was applied to the entire affected areas on the face twice a day. Reference: A thin layer of gel was applied to the entire affected areas on the face twice a day. Placebo: A thin layer of gel was applied to the entire affected areas on the face twice a day.
Period Title: Overall Study
Started 440 440 220
Completed 409 417 203
Not Completed 31 23 17
Arm/Group Title Test Reference Placebo Total
Hide Arm/Group Description Test: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel Reference: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% Placebo: Placebo topical gel Total of all reporting groups
Overall Number of Baseline Participants 432 430 211 1073
Hide Baseline Analysis Population Description
A total of 1100 subjects were randomized in the study; of these 27 subjects did not received the dose (Test=8, Reference=10, Placebo=9) and were excluded from the safety population randomized. Therefore the overall number of subjects in the Baseline Participants module is not consistent with any of the rows of the Participant Flow module.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 432 participants 430 participants 211 participants 1073 participants
22.8  (7.7) 22.3  (7.6) 22.6  (7.5) 22.6  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 432 participants 430 participants 211 participants 1073 participants
Female 274 259 127 660
Male 158 171 84 413
1.Primary Outcome
Title Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)
Hide Description The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated.
Time Frame Baseline and 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Test Reference Placebo
Hide Arm/Group Description:
Clindamycin and Benzoyl Peroxide Gel, 1%/5%
BenzaClin® Topical Gel: Clindamycin and Benzoyl Peroxide Gel, 1%/5%
Placebo: Placebo topical gel
Overall Number of Participants Analyzed 362 368 176
Mean (Standard Deviation)
Unit of Measure: percentage change from baseline
72.3  (25.2) 71.1  (26.7) 39.1  (31.4)
2.Primary Outcome
Title Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones)
Hide Description The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated.
Time Frame Baseline and 10 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Test Reference Placebo
Hide Arm/Group Description:
Clindamycin and Benzoyl Peroxide Gel, 1%/5%
BenzaClin® Topical Gel: Clindamycin and Benzoyl Peroxide Gel, 1%/5%
Placebo: Placebo Topical Gel
Overall Number of Participants Analyzed 362 368 176
Mean (Standard Deviation)
Unit of Measure: Percentage change from baseline
64.5  (24.7) 63.3  (26.2) 30.9  (28.5)
Time Frame [Not Specified]
Adverse Event Reporting Description A total of 1100 subjects were randomized in the study; of these 27 subjects did not received the dose (Test=8, Reference=10, Placebo=9) and were excluded from the safety population randomized. Therefore the total number of Participants at risk is not consistent with any of the rows of the Participant Flow module.
 
Arm/Group Title Test Reference Placebo
Hide Arm/Group Description Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% Placebo topical gel
All-Cause Mortality
Test Reference Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Test Reference Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/432 (0.00%)   0/430 (0.00%)   0/211 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Test Reference Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/432 (0.00%)   0/430 (0.00%)   0/211 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Per the agreement, Sponsor reserves the right for publishing trial results and the Investigator cannot publish without written consent from the Sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Cathy Tyrrell
Organization: Glenmark Pharmaceuticals Ltd
Phone: 91 2267720000
EMail: clinicaltrialsdisclosuredesk@glenmarkpharma.com
Layout table for additonal information
Responsible Party: Glenmark Pharmaceuticals Ltd. India
ClinicalTrials.gov Identifier: NCT02465632     History of Changes
Other Study ID Numbers: GLK-1403
First Submitted: June 4, 2015
First Posted: June 8, 2015
Results First Submitted: April 18, 2017
Results First Posted: June 28, 2017
Last Update Posted: June 28, 2017