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Bioequivalence Study of Adapalene Gel 0.3% in Subjects With Facial Acne Vulgaris

NCT03650361 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 755

Last updated 2019-04-26

No results posted yet for this study

Summary

To evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% (Aleor Dermaceuticals Limited, India) and Differin® (Adapalene) Gel 0.3% (Galderma Laboratories, LP USA) in the treatment of acne vulgaris.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Adapalene Gel 0.3%

Treatment applied as a thin layer of the product to the entire face once a day in the evening for 84 days

DRUG

Differin 0.3% Topical Gel

Treatment applied as a thin layer of the product to the entire face once a day in the evening for 84 days

DRUG

Adapalene Gel 0.3% Vehicle Placebo

Treatment applied as a thin layer of the product to the entire face once a day in the evening for 84 days

Sponsors & Collaborators

  • Catawba Research, LLC

    collaborator UNKNOWN

  • Aleor Dermaceuticals Limited

    lead INDUSTRY

Principal Investigators

  • Venkata. K. R. CH. Hemanth Varma. P · Aleor Dermaceuticals Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-09-17
Primary Completion
2019-02-16
Completion
2019-02-16
FDA Drug
Yes

Countries

  • United States
  • Belize

Study Locations

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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 NCT03650361 on ClinicalTrials.gov