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A Study Comparing Adapalene Gel 0.1% and to Differin Gel in the Treatment of Acne Vulgaris

NCT04797793 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 978

Last updated 2021-04-01

No results posted yet for this study

Summary

To demonstrate therapeutic equivalence and safety of adapalene gel 0.1% (Taro Pharmaceuticals U.S.A., Inc.) and Differin® Gel (Adapalene Gel 0.1%, Galderma) in the treatment of acne vulgaris.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Adapalene Gel 0.1%

The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.

DRUG

Placebo Control

The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.

DRUG

Differin® Gel (Adapalene 0.1%, Galderma)

The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Principal Investigators

  • Zaidoon A. Al-Zubaidy · Catawba Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-18
Primary Completion
2021-01-08
Completion
2021-01-08
FDA Drug
Yes

Countries

  • United States

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 NCT04797793 on ClinicalTrials.gov