Actively Recruiting
Randomized Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients: ETHNIC Study
Led by Centre Hospitalier Universitaire de Nice · Updated on 2026-05-20
420
Participants Needed
19
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for moderate acne in patients with darker skin types (Fitzpatrick phototypes IV-VI), focusing on acne-related pigmentation that affects quality of life. This randomized controlled trial compares oral isotretinoin as a first-line treatment against the current standard of care involving oral antibiotics and topical creams. The study aims to assess which approach better improves pigmentation severity after six months. Participants will be assigned to one of two groups. One group receives oral isotretinoin starting at 0.5 mg/kg daily for six months, with dose adjustments possible based on tolerance and effectiveness. The other group follows standard care, receiving topical tretinoin or adapalene along with doxycycline or lymecycline for three months, followed by evaluation at three and six months. Dose changes may occur according to clinical response. During the study, participants will attend monthly visits if receiving isotretinoin or visits at three and six months for the standard care group. Researchers will assess acne-related pigmentation severity, quality of life, and any adverse events. Participants must have a cell phone capable of taking high-definition selfies to assist in monitoring. The total study duration for each participant is six months, with ongoing safety and effectiveness checks.
CONDITIONS
Brief Title
Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women and men between 13 and 30 years old
- Fitzpatrick skin types IV, V, or VI (darker skin tones)
- Moderate acne according to French Society of Dermatology recommendations based on ECLA grading
- Ability to use a cell phone with a camera of at least 5 Megapixels for selfies
- Signed informed consent
- Affiliated with French social coverage
You will not qualify if you...
- Mild or severe acne according to ECLA grading
- Previous treatment with oral isotretinoin
- Use of systemic antibiotics for acne within the last 6 months
- Fitzpatrick skin types I to III
- Abnormal blood counts, liver enzymes, cholesterol, or triglycerides at baseline
- Pregnancy or breastfeeding
- Refusal to use effective contraception for women of childbearing potential
- Contraindications to isotretinoin, doxycycline, lymecycline, or topical adapalene/tretinoin
- Vulnerable individuals under guardianship or deprived of liberty
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either oral isotretinoin or standard of care including topical creams and antibiotics. Those on isotretinoin start at 0.5 mg/kg/day with possible dose adjustments after 3 months based on efficacy and tolerance. Those on standard care use topical tretinoin or adapalene daily with antibiotics for the first 3 months, followed by topical treatment alone if improved.
Monthly visits for up to 6 months for isotretinoin group; visits at 3 and 6 months for standard of care group
Trial Site Locations
Total: 19 locations
1
CHU de Nice - Hôpital de l'Archet
Nice, Alpes-Maritimes, France, 06200
Actively Recruiting
2
CHU de Bordeaux
Bordeaux, Aquitaine, France, 33000
Actively Recruiting
3
CHU de Nantes
Nantes, Loire-Atlantique, France, 44 000
Actively Recruiting
4
chu de Rouen
Rouen, Seine-maritime, France, 76000
Actively Recruiting
5
Cabinet de dermatologie St Maxime
Sainte-Maxime, Var, France, 83000
Actively Recruiting
6
CH D'argenteuil
Argenteuil, France
Actively Recruiting
7
Cabinet Dermatologique Brest 1
Brest, France
Actively Recruiting
8
Cabinet Dermatologique Brest 2
Brest, France
Actively Recruiting
9
Cabinet dermatologique Cenon
Cenon, France
Not Yet Recruiting
10
Cabinet dermatologique gradignan
Gradignan, France
Actively Recruiting
11
CHU de la réunion
La Réunion, France
Actively Recruiting
12
Ambroise paré
Paris, France
Actively Recruiting
13
Cabinet dermatologique privé
Paris, France
Not Yet Recruiting
14
Cabinet dermatologique
Paris, France
Actively Recruiting
15
CH Avicenne - APHP
Paris, France
Actively Recruiting
16
CHU de Poitiers
Poitiers, France
Actively Recruiting
17
APHP
Paris, Île-de-France Region, France, 75000
Actively Recruiting
18
CH de Cayenne 3 Avenue Alexis Blaise, BP6006
Cayenne, French Guiana, 97306
Actively Recruiting
19
Cabinet de dermatologie DERMACLINIC 972
Fort-de France, French Guiana
Actively Recruiting
Research Team
T
Thierry Passeron, PhD
E
Emmanuelle Pradelli
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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