CompletedNCT02465632Updated Jun 28, 2017Results posted

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

A Phase 3 interventional study of Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% in Acne Vulgaris, sponsored by Glenmark Pharmaceuticals Ltd. India. Completed at 15 sites in 2 countries. Open to participants aged 12 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-06-28.

Sponsored by Glenmark Pharmaceuticals Ltd. India · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 1,100
Allocation: Randomized
Ages: 12 Years to 40 Years
Sex: All

Study 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.

Conditions studied

Acne Vulgaris

Browse trials for

Acne Vulgaris 790

In context

Acne Vulgaris

790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.

This study's enrollment of 1,100 is above the median of 70 across 672 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Glenmark Pharmaceuticals Ltd. India is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years to 40 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 1,100 participants (actual)

Study arms

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

Interventions

DrugClindamycin 1%/Benzoyl Peroxide 5% Topical Gel
Drug page: Clindamycin
DrugBenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
DrugPlacebo

What researchers measure

Primary outcomes

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.
Time frame: Baseline and 10 Weeks
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.
Time frame: Baseline and 10 Weeks

Results

Posted Jun 28, 2017

Participant flow

Participant flow — Overall Study
Milestone	Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel	BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%	Placebo Topical Gel
Started	440	440	220
Completed	409	417	203
Not completed	31	23	17

Outcome measures

PrimaryMean 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.

Time frame:: Baseline and 10 Weeks
Reported as:: Mean · percentage change from baseline

Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)
percentage change from baseline	Test	Reference	Placebo
Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)	72.3 ± 25.2	71.1 ± 26.7	39.1 ± 31.4

PrimaryMean 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.

Time frame:: Baseline and 10 Weeks
Reported as:: Mean · Percentage change from baseline

Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones)
Percentage change from baseline	Test	Reference	Placebo
Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones)	64.5 ± 24.7	63.3 ± 26.2	30.9 ± 28.5

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Test	—	0/432 (0%)	0/432 (0%)
Reference	—	0/430 (0%)	0/430 (0%)
Placebo	—	0/211 (0%)	0/211 (0%)

Baseline characteristics

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
Age, Continuous(years)	Test	Reference	Placebo	Total
Mean	22.8 ± 7.7	22.3 ± 7.6	22.6 ± 7.5	22.6 ± 7.6

Sex: Female, Male
Sex: Female, Male(Participants)	Test	Reference	Placebo	Total
Female	274	259	127	660
Male	158	171	84	413

Study locations

15 sites

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
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
Glenmark Investigational Site 5
Louisville, Kentucky, United States
Glenmark Investigational Site7
Upper Saint Clair, Pennsylvania, United States
Glenmark Investigational Site 14
Greenville, South Carolina, United States
Glenmark Investigational Site 3
Nashville, Tennessee, United States
Glenmark Investigational Site 10
Belize City, Belize
Glenmark Investigational Site 11
Belize City, Belize

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2015, a primary completion of Nov 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.

Results were first posted in Jun 2017, 1 year 7 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 4, 2015
First posted: Jun 8, 2015
Start: Apr 2015
Primary completionActual: Nov 2015
CompletionActual: Dec 2015
Results first posted: Jun 28, 2017
Last update: Jun 28, 2017

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jun 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02465632
Lead sponsor: Glenmark Pharmaceuticals Ltd. India
Responsible party: Sponsor
First posted: Jun 8, 2015
Start date: Apr 2015
Primary completion: Nov 2015
Completion: Dec 2015
Results posted: Jun 28, 2017
Last update: Jun 28, 2017

Study contacts

Mahesh V Deshpande

study director · Glenmark Pharmaceuticals Ltd

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Clindamycin

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