Trifarotene 0.005 % Topical Cream for Acne

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Site 10011, New Orleans, LA
Acne
Trifarotene 0.005 % Topical Cream - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 12 Weeks

12 Weeks
Primary Endpoint

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

AKLIEF®
1 of 3
Test: Trifarotene Cream, 0.005%
1 of 3
Vehicle Product
1 of 3
Active Control
Experimental Treatment
Non-Treatment Group

807 Total Participants · 3 Treatment Groups

Primary Treatment: Trifarotene 0.005 % Topical Cream · Has Placebo Group · Phase 3

Test: Trifarotene Cream, 0.005%
Drug
Experimental Group · 1 Intervention: Trifarotene 0.005 % Topical Cream · Intervention Types: Drug
AKLIEF®
Drug
ActiveComparator Group · 1 Intervention: AKLIEF® · Intervention Types: Drug
Vehicle Product
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
Closest Location: Site 10011 · New Orleans, LA
Photo of New Orleans 1Photo of New Orleans 2Photo of New Orleans 3
N/AFirst Recorded Clinical Trial
0 TrialsResearching Acne
0 CompletedClinical Trials

Who is running the clinical trial?

Teva Pharmaceuticals USALead Sponsor
226 Previous Clinical Trials
180,782 Total Patients Enrolled
Teva Pharmaceuticals, Inc.Industry Sponsor

Eligibility Criteria

Age < 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Subjects who worsen beyond Grade 4 will be described in the safety evaluation
You are female and not pregnant or lactating at the time of screening/baseline visit.
You are between 12 and 40 years of age
Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB/IEC approved written informed consent
Subjects must have ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤ 2 nodulocystic lesions (i.e.
Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below) at screening/baseline.
Subjects must be willing to refrain from using all other topical acne medications or antibiotics during the 12-week treatment period, other than the investigational product.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.