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

• Sponsor: Glenmark Pharmaceuticals Ltd. India (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02465632
• Collaborator: (none)
• Enrollment: 1,100
• Locations: 15
• Arms: 3
• Duration (Months): 8
• Patients Per Site: 73.3
• Patients Per Site Per Month: 9.1

Study Details

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.

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 Design

• Study Type: Interventional
• 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: Apr 1, 2015
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules) [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) [Baseline and 10 Weeks]

   The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Glenmark Pharmaceuticals Ltd. India

Investigators

• Study Director: Mahesh V Deshpande, Glenmark Pharmaceuticals Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Glenmark Pharmaceuticals Ltd. India
• ClinicalTrials.gov Identifier: NCT02465632
• Other Study ID Numbers: GLK-1403
• First Posted: Jun 8, 2015
• Last Update Posted: Jun 28, 2017
• Last Verified: Dec 1, 2015

• Additional relevant MeSH terms: Acne Vulgaris; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide

Study Results

Participant Flow

Arm/Group Title	Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel	BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%	Placebo Topical Gel
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

Baseline Characteristics

Arm/Group Title	Test	Reference	Placebo	Total
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 Participants	432	430	211	1073
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	22.8 (7.7)	22.3 (7.6)	22.6 (7.5)	22.6 (7.6)
Sex: Female, Male (Count of Participants)
Female	274 63.4%	259 60.2%	127 60.2%	660 61.5%
Male	158 36.6%	171 39.8%	84 39.8%	413 38.5%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test	Reference	Placebo
Arm/Group Description	Clindamycin and Benzoyl Peroxide Gel, 1%/5%	BenzaClin® Topical Gel: Clindamycin and Benzoyl Peroxide Gel, 1%/5%	Placebo: Placebo topical gel
Measure Participants	362	368	176
Mean (Standard Deviation) [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)
Description	The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated.
Time Frame	Baseline and 10 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test	Reference	Placebo
Arm/Group Description	Clindamycin and Benzoyl Peroxide Gel, 1%/5%	BenzaClin® Topical Gel: Clindamycin and Benzoyl Peroxide Gel, 1%/5%	Placebo: Placebo Topical Gel
Measure Participants	362	368	176
Mean (Standard Deviation) [Percentage change from baseline]	64.5 (24.7)	63.3 (26.2)	30.9 (28.5)

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Test		Reference		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/432 (0%)		0/430 (0%)		0/211 (0%)
Other (Not Including Serious) Adverse Events
	Test		Reference		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/432 (0%)		0/430 (0%)		0/211 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Per the agreement, Sponsor reserves the right for publishing trial results and the Investigator cannot publish without written consent from the Sponsor.