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Retinoid

Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation (START 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, week 24
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is testing a cream with trifarotene to see if it can reduce the risk of developing scars in people with facial acne. The cream works by helping skin cells renew faster, which can prevent clogged pores and reduce inflammation. The study will compare the effects of the trifarotene cream to another cream over several months. Trifarotene has been shown to be effective in treating both facial and truncal acne in previous studies.

Eligible Conditions
  • Acne
  • Acne Vulgaris

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 24 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 Total Atrophic Acne Scar Count Per Half Face at Week 24
Secondary study objectives
Absolute Change From Baseline in Total Atrophic Acne Scar Count Per Half-Face up to Week 20

Side effects data

From 2023 Phase 4 trial • 121 Patients • NCT04856904
8%
COVID-19
2%
Skin laceration
2%
Nasopharyngitis
2%
Pruritus
2%
Rash
2%
Skin tightness
2%
SARS-CoV-2 test positive
1%
Food allergy
1%
Haemorrhoids
1%
Arthropod bite
1%
Face oedema
1%
Burning sensation
1%
Accidental exposure to product
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%
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
60,547 Total Patients Enrolled
11 Trials studying Acne
1,464 Patients Enrolled for Acne
~27 spots leftby Dec 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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