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Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris

NCT05550337 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 807

Last updated 2024-09-26

Study results available
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Summary

To compare the safety and efficacy of the test (Trifarotene 0.005% cream), placebo (vehicle cream) and reference AKLIEF® (Trifarotene 0.005% cream) treatments to demonstrate clinical equivalence in subjects with acne vulgaris.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Trifarotene 0.005 % Topical Cream

Cream

DRUG

AKLIEF®

Cream

DRUG

Placebo

Cream

Sponsors & Collaborators

  • Teva Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Teva Pharmaceuticals USA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-09-19
Primary Completion
2023-05-09
Completion
2023-05-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT05550337 on ClinicalTrials.gov