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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 12 weeks
Awards & highlights

Study Summary

This trial is testing whether Trifarotene cream is effective and safe for treating acne vulgaris, compared to a placebo cream and a reference cream.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Endpoint

Side effects data

From 2021 Phase 4 trial • 202 Patients • NCT04451330
1%
Self-Injurious Ideation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trifarotene + Doxycycline
Trifarotene Vehicle + Doxycycline Placebo

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
187,393 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are enrolled in this trial?

"Yes, this research study is looking for volunteers right now. The trial was advertised on September 19th 2022 and has since been updated on November 4th of the same year. So far, 807 individuals have signed up at one of the 12 clinical trial sites."

Answered by AI

Does this experiment welcome elderly test subjects?

"The age restrictions for this trial are 12-40, as per the inclusion criteria."

Answered by AI

Where can patients enroll in this research project?

"A few of the 12 locations where this trial is running are Site 10001 in Brandon, Texas, Site 10007 in El Paso, New mexico, and Site 10003 in Fort Lauderdale."

Answered by AI

Is it dangerous to use Trifarotene 0.005 % Topical Cream?

"Trifarotene 0.005 % Topical Cream is in Phase 3 of clinical trials, which means that there is both evidence of efficacy and multiple rounds of data supporting safety. Therefore, it received a score of 3 for safety."

Answered by AI

Are there any current open positions for participants in this clinical trial?

"Yes, this is an active trial that has been recruiting since September 19th, 2020. They are looking for 807 people to participate at 12 different sites."

Answered by AI

How can I sign up to help with this research?

"This medical trial is seeking 807 acne sufferers between the ages of 12 and 40. Eligible applicants must meet the following requirements: (a) For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. All lesions will be counted, including those present on the nose. Subjects may have acne lesions on other areas of the body which will be excluded from the count and the Investigator's Global Assessment (IGA) evaluation (e.g., on the back, chest and arms)., Table 1: Investigator's Global Assessment (IGA) Scale for Acne Vulgaris Grade Description"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris
2022. "Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05550337.
~312 spots leftby Apr 2025
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