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Anti-acne medication

Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel for Acne Vulgaris

Phase 3
Waitlist Available
Research Sponsored by Glenmark Pharmaceuticals Ltd. India
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 10 weeks
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial

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.

Eligible Conditions
  • Acne Vulgaris
  • Acne

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)
Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Clindamycin 1%/Benzoyl Peroxide 5% Topical GelExperimental Treatment1 Intervention
apply a thin layer of gel to the face
Group II: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%Active Control1 Intervention
apply a thin layer of the gel to the face
Group III: Placebo topical gelPlacebo Group1 Intervention
apply a thin layer of the gel to the face
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clindamycin
FDA approved

Find a Location

Who is running the clinical trial?

Glenmark Pharmaceuticals Ltd. IndiaLead Sponsor
16 Previous Clinical Trials
8,005 Total Patients Enrolled
Mahesh V DeshpandeStudy DirectorGlenmark Pharmaceuticals Ltd
1 Previous Clinical Trials
1,164 Total Patients Enrolled
~104 spots leftby Nov 2025
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