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Retinoid

Trifarotene Cream for Acne (LEAP Trial)

Phase 4
Waitlist Available
Research Sponsored by Galderma R&D
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, at week 12, week 16 and week 20
Awards & highlights

LEAP Trial Summary

This trial is testing a new acne cream to see if it's better than the existing one at preventing post-inflammatory hyperpigmentation.

Eligible Conditions
  • Acne

LEAP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, at week 12, week 16 and week 20
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, at week 12, week 16 and week 20 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity (ODS) Scores at Week 24
Secondary outcome measures
Absolute Change From Baseline in PIH ODS Scores at Weeks 12, 16 and 20
Percent Change From Baseline in PIH ODS Scores at Week 24
Percent Change From Baseline in PIH Overall Disease Severity Scores at Weeks 12, 16 and 20

Side effects data

From 2022 Phase 4 trial • 123 Patients • NCT05089708
5%
COVID-19
3%
Influenza
3%
Nasopharyngitis
2%
Muscle spasms
2%
Attention deficit hyperactivity disorder
2%
Vomiting
2%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trifarotene (CD5789) Cream
Trifarotene Vehicle Cream

LEAP Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Trifarotene (CD5789) 50 mcg/g CreamExperimental Treatment1 Intervention
Group II: Trifarotene Vehicle CreamPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trifarotene Cream
2021
Completed Phase 4
~250

Find a Location

Who is running the clinical trial?

Galderma R&DLead Sponsor
298 Previous Clinical Trials
60,195 Total Patients Enrolled
11 Trials studying Acne
1,464 Patients Enrolled for Acne

Frequently Asked Questions

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

Are there any particular individuals that are more suitable for enrollment in this clinical investigation?

"Candidates are sought to join this experiment, requiring they possess acne and stand between their teenage years and mid-thirties. A total of 120 participants will be accepted in the study."

Answered by AI

Are octogenarians being admitted to this clinical experiment?

"The eligibility requirements for this clinical trial stipulate that participants must be between 13 and 35 years old. There are 18 studies available to minors, while 27 trials cater towards those above the age of 65."

Answered by AI

Has Trifarotene Cream received federal authorization?

"Accurate data on Trifarotene Cream's safety is available, so it was rated a 3. This product has also been approved for use and is currently in Phase 4 clinical trials."

Answered by AI

What is the number of healthcare institutions utilizing this experimental trial?

"The current study has 22 sites of operation, spanning from Evansville to Fountain Valley and San Diego. To reduce the amount of travel needed for participation, it is suggested that individuals look for a clinic in their vicinity."

Answered by AI

Is there additional research available concerning the efficacy of Trifarotene Cream?

"Currently, there is a pair of live studies evaluating the efficacy of Trifarotene Cream with no trials in Phase 3. 43 separate medical establishments are participating in these trials and most of them are located in Arlington, Texas."

Answered by AI

How many participants are actively engaging in this research project?

"This medical trial is no longer accepting participants. It was posted on December 27th 2021, and the last update occured on July 28th 2022. If you are looking to join a different research study, there are 46 trials recruiting individuals with acne and 2 studies searching for volunteers to use Trifarotene Cream."

Answered by AI

Are there any opportunities to join this trial at the present time?

"This clinical trial is not currently enrolling patients; the initial post date was December 27th 2021 and it was last updated on July 28th 2022. However, there are 48 other studies that have open recruitment presently."

Answered by AI

Is this experiment unprecedented in its approach?

"The journey of Trifarotene Cream began in 2021, when it was first researched under the patronage of Galderma R&D. After a successful Phase 1 trial involving 118 participants, this cream ultimately achieved its drug approval status. Currently there are two active clinical trials for Trifarotene Cream that span 4 countries and 34 cities."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Galderma Investigational Site #8620
What portion of applicants met pre-screening criteria?
Met criteria
~38 spots leftby Apr 2025