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Anti-acne medication

Test-Cadila healthcare limited for Acne

Phase 3
Waitlist Available
Research Sponsored by Cadila Healthcare Limited
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 week 11
Awards & highlights

Study Summary

This is an Randomized, Double-blind, Multicentric, Parallel-group, Active and Placebo Controlled, Three Arm Clinical Study. The main objective is to evaluate bioequivalence of Test formulation (Clindamycin Phosphate 1.2%/Benzoyl peroxide 5% gel) of Cadila Healthcare with Reference formulation (DUAC® Gel of Stiefel Laboratories)in the ratio of 2:2:1 of Test drug, Reference drug and Placebo respectively. Total study duration will be for a period of 78 days which includes treatment duration of 77 days. 850 subjects will be enrolled (randomized)as per the inclusion and exclusion criteria mentioned in the protocol.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 11
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 11 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Percent Change From Baseline to Week 11 (Study Day 77) for Inflammatory (Papules and Pustules) Lesions.
Secondary outcome measures
Mean Percent Change From Baseline to Week 11 in the Non-inflammatory Lesion Count
Proportion of Subjects With a Clinical Response of "Success" at Week 11

Side effects data

From 2016 Phase 3 trial • 850 Patients • NCT02005666
3%
Nasopharyngitis
3%
Headache
2%
Application site dryness
2%
Pyrexia
1%
Nasal congestion
1%
Nausea
1%
Diarrhoea
1%
Application site erythema
1%
Cough
1%
Application site pruritus
1%
Upper respiratory tract infection
1%
Hyperchlorhydria
1%
Oropharyngeal pain
1%
Rhinorrhoea
1%
Dysmenorrhoea
1%
Application site pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Test-Cadila Healthcare Limited
Reference-DUAC® Gel
Placebo

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Test-Cadila healthcare limitedExperimental Treatment1 Intervention
Drug:-Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
Group II: ReferenceActive Control1 Intervention
Drug:-DUAC® Gel (of Stiefel Laboratories, USA) Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
Group III: PlaceboPlacebo Group1 Intervention
Drug:-Placebo (Vehicle Gel) Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benzoyl peroxide
FDA approved

Find a Location

Who is running the clinical trial?

Cadila Healthcare LimitedLead Sponsor
16 Previous Clinical Trials
2,751 Total Patients Enrolled
Zydus Lifesciences LimitedLead Sponsor
20 Previous Clinical Trials
4,335 Total Patients Enrolled
Dr Dharmesh Domadia, M.DStudy DirectorCliantha Research Limited

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
To Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel of CHL Versus DUAC® Gel
2013. "To Compare the Efficacy and Safety of Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel of CHL Versus DUAC® Gel". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02005666.
~74 spots leftby May 2025
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