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Retinoid

Trifarotene Cream for Acne Vulgaris (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
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is testing a special cream with Trifarotene to treat people with moderate facial acne who might get dark spots after their acne heals. The cream works by helping the skin shed old cells faster and keeping pores open. Trifarotene has been shown to be effective and well-tolerated in treating both facial and body acne.

Eligible Conditions
  • Acne Vulgaris
  • Acne

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Absolute Change From Baseline in Post-Inflammatory Hyperpigmentation (PIH) Overall Disease Severity (ODS) Scores at Week 24
Secondary study objectives
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 2023 Phase 4 trial • 121 Patients • NCT04856904
8%
COVID-19
2%
Nasopharyngitis
2%
Pruritus
2%
Rash
2%
Skin tightness
2%
Skin laceration
2%
SARS-CoV-2 test positive
1%
Haemorrhoids
1%
Burning sensation
1%
Food allergy
1%
Face oedema
1%
Hand fracture
1%
Hyperaesthesia teeth
1%
Influenza like illness
1%
Vaccination site pain
1%
Adverse reaction
1%
Neck pain
1%
Gastroenteritis viral
1%
Kidney infection
1%
Tooth abscess
1%
Urinary tract infection
1%
Viral infection
1%
Dermatitis contact
1%
Erythema
1%
Skin irritation
1%
Abdominal pain
1%
Dyspepsia
1%
Food poisoning
1%
Nausea
1%
Vomiting
1%
Accidental exposure to product
1%
Arthropod bite
1%
Headache
1%
Presyncope
1%
Somnolence
1%
Agitation
1%
Anxiety
1%
Epistaxis
1%
Sinus congestion
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Acne Vulgaris Participants
Trifarotene Vehicle Cream
Trifarotene 50mcg/g Cream

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
302 Previous Clinical Trials
60,564 Total Patients Enrolled
47 Trials studying Acne Vulgaris
15,400 Patients Enrolled for Acne Vulgaris
~32 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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