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Clinical Endpoint Bioequivalence Study of Adapalene Gel 0.1%

NCT04329403 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2020-06-26

No results posted yet for this study

Summary

To evaluate the therapeutic equivalence of topical Adapalene Gel, 0.1 % and Differin®(Adapalene) Gel, 0.1 % in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Adapalene 0.1% Gel

A thin film of the assigned medication to be applied once daily in the evening for 12 weeks

DRUG

Differin 0.1% Topical Gel

A thin film of the assigned medication to be applied once daily in the evening for 12 weeks

OTHER

Placebo

A thin film of the assigned medication to be applied once daily in the evening for 12 weeks

Sponsors & Collaborators

  • Aurobindo Pharma Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-31
Primary Completion
2021-01-31
Completion
2021-05-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04329403 on ClinicalTrials.gov