Comparing Isotretinoin to Standard Care for Moderate Acne in Skin of Color
Randomized Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients: ETHNIC Study
This study is testing whether the acne medication isotretinoin works better than standard treatments for young people with moderate acne and skin of color.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 13 Years to 30 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 16 sites (Nice, Alpes-Maritimes and 15 other locations) |
| Trial ID | NCT06447480 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of oral isotretinoin compared to standard care in treating moderate acne in patients with skin types IV to VI, which are often underrepresented in clinical research. The study focuses on individuals aged 13 to 30 who experience moderate acne, characterized by specific lesions and associated pigmentation issues. Participants will receive isotretinoin and topical treatments while their progress will be monitored through selfies taken with their cell phones. The trial seeks to address the unique challenges faced by patients of color in managing acne and its effects on quality of life.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 13 to 30 with Fitzpatrick skin types IV to VI and moderate acne.
Not a fit: Patients with mild or severe acne, or those with skin types I to III, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for moderate acne in patients with darker skin types, improving their quality of life.
How similar studies have performed: While there is limited research specifically targeting this demographic, the approach of using isotretinoin for acne treatment has shown success in other populations, making this study a potentially valuable addition to existing knowledge.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women and men between 13 and 30-year-old * Skin type IV, V and VI according to Fitzpatrick skin types * Moderate acne as defined by the French Society of Dermatology recommendations based on ECLA grading https://document.sfdermato.org/groupe/centre-de-preuves/label-recommandations-acne-post-college.pdf) * Patients must have a cell phone able to take selfies pictures with a minimum definition of 5Mb. * Signed informed consent * Affiliation to French social coverage. Exclusion Criteria: * Mild and severe acne (ECLA grading : French recommendations) (https://document.sfdermato.org/groupe/centre-de-preuves/label-recommandations-acne-post-college.pdf) * Past cure of oral isotretinoin * Past cure of systemic antibiotics for acne in the last 6 months * Phototype I-III patients * Abnormal hemogram, liver enzyme, cholesterol, triglycerides at baseline * Pregnancy: female patient of childbearing potential will undergo a pregnancy test (plasmatic β-hCG) * Breast-feeding patients * Refusal of effective contraception for women * Contra-indications to oral isotretinoin, doxycycline, lymecycline, topical adapalene/tretinoin * Vulnerable people: adult under guardianship or deprived of freedom
Where this trial is running
Nice, Alpes-Maritimes and 15 other locations
- CHU de Nice - Hôpital de l'Archet — Nice, Alpes-Maritimes, France (Recruiting)
- CHU de Bordeaux — Bordeaux, Aquitaine, France (Recruiting)
- CHU de Nantes — Nantes, Loire-Atlantique, France (Recruiting)
- chu de Rouen — Rouen, Seine-maritime, France (Not_yet_recruiting)
- Cabinet de dermatologie St Maxime — Sainte-Maxime, Var, France (Not_yet_recruiting)
- CH D'argenteuil — Argenteuil, France (Recruiting)
- Cabinet Dermatologique Brest 1 — Brest, France (Not_yet_recruiting)
- Cabinet Dermatologique Brest 2 — Brest, France (Not_yet_recruiting)
- Cabinet dermatologique Cenon — Cenon, France (Not_yet_recruiting)
- Cabinet dermatologique gradignan — Gradignan, France (Not_yet_recruiting)
- CHU de la réunion — La Réunion, France (Recruiting)
- Cabinet dermatologique privé — Paris, France (Not_yet_recruiting)
- CH Avicenne - APHP — Paris, France (Not_yet_recruiting)
- Hôpital Béclére — Paris, France (Not_yet_recruiting)
- Aphp — Paris, Île-de-France Region, France (Recruiting)
- CH de Cayenne 3 Avenue Alexis Blaise, BP6006 — Cayenne, French Guiana (Recruiting)
Study contacts
- Principal investigator: Thierry Passeron, PhD — CHU de Nice, Service de Dermatologie
- Study coordinator: Thierry Passeron, PhD
- Email: passeron.t@chu-nice.fr
- Phone: +33492036488
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.