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Retinoid

Trifarotene 0.005 % Topical Cream for Acne

Phase 3
Waitlist Available
Research Sponsored by Teva Pharmaceuticals USA
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 baseline and 12 weeks
Awards & highlights
Pivotal Trial

Summary

This trial is testing a cream called Trifarotene to see if it is safe and effective for treating acne. Trifarotene is a newly FDA-labeled fourth-generation topical retinoid that shows promise in treating facial and truncal acne vulgaris. The study involves patients with acne who will use either the Trifarotene cream or another cream. The goal is to see if Trifarotene can help clear up acne by normalizing skin cell growth and reducing inflammation.

Eligible Conditions
  • Acne
  • Acne Vulgaris

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Change in Inflammatory Lesion Counts
Primary Change in Non-Inflammatory Lesion Count

Side effects data

From 2023 Phase 3 trial • 807 Patients • NCT05550337
1%
Headache
1%
Nasal congestion
1%
Cough
1%
Oropharyngeal pain
1%
Skin burning sensation
1%
Rhinorrhoea
1%
Nasopharyngitis
1%
Application site dryness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Test: Trifarotene Cream, 0.005%
AKLIEF®
Vehicle Product

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Test: Trifarotene Cream, 0.005%Experimental Treatment1 Intervention
Trifarotene Cream, 0.005%, Apply to the affected areas of the face once daily for 84 days.
Group II: AKLIEF®Active Control1 Intervention
AKLIEF® (Trifarotene Cream, 0.005%), Apply to the affected areas of the face once daily for 84 days.
Group III: Vehicle ProductPlacebo Group1 Intervention
Vehicle of the Test Product, Cream, Apply to the affected areas of the face once daily for 84 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trifarotene 0.005 % Topical Cream
2022
Completed Phase 3
~810

Find a Location

Who is running the clinical trial?

Teva Pharmaceuticals, Inc.Industry Sponsor
Teva Pharmaceuticals USALead Sponsor
230 Previous Clinical Trials
187,401 Total Patients Enrolled
~255 spots leftby Nov 2025
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