Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients
Recruiting now · Phase 3
Conditions studied: Acne Vulgaris
In brief
In Dermatology, assessment of people of color remains underrepresented in RCTs (\<10%) and guidelines. Acne affects around 9% of the population worldwide and negatively affects quality of life and self-esteem with anxiety, suicidal ideation and physical scarring. Main lesions associate comedons, inflammatory papules and pustules which grading of severity allows decision-making, e.g., topicals in mild acne and isotretinoin in severe acne. In darker skin type patients, i.e., Fitzpatrick phototypes IV-VI, acne-related pigmentation (ARP) occurs in 65% of cases which reflects either per- or post-inflammatory hyperpigmentation. Whatever is the mechanism, ARP (number, size, importance of dyschromia) impacts the quality of life in such patients. In moderate acne, treatment is based on oral antibiotics for 3 months, i.e., doxycycline or lymecycline, with topical treatment like tretinoin targeting comedons (and potentially ARP). However, oral antibiotics first-line were developed in white skin patients only and never showed its efficacy in ARP. Moreover, doxycycline could be associated with new-onset hyperpigmentation in acne patients. Isotretinoin -acting on the sebaceous gland and therefore the most effective drug in acne- is only prescribed after failure of antibiotics according to the guidelines.The main objective: To assess the superiority at M6 of a treatment of moderate facial acne in skin of color patients with oral isotretinoin in first line compared to the current standard of care on the severity of ARP.Multicenter randomized controlled trial - open study. The number of subjects required for the trial = 420
Key facts
- Study ID
- NCT06447480
- Run by
- Centre Hospitalier Universitaire de Nice
- People needed
- 420
- Starts
- 2025-04-29
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2026-05-20
Who can join
Age: 13 and older, up to 30. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Cabinet de dermatologie DERMACLINIC 972 — Fort-de France, French Guiana (enrolling)
- CHU de Bordeaux — Bordeaux, Aquitaine, France (enrolling)
- CHU de Nantes — Nantes, Loire-Atlantique, France (enrolling)
- chu de Rouen — Rouen, Seine-maritime, France (enrolling)
- Cabinet de dermatologie St Maxime — Sainte-Maxime, Var, France (enrolling)
- CH D'argenteuil — Argenteuil, France (enrolling)
- Cabinet Dermatologique Brest 1 — Brest, France (enrolling)
- Cabinet Dermatologique Brest 2 — Brest, France (enrolling)
- CH de Cayenne 3 Avenue Alexis Blaise, BP6006 — Cayenne, French Guiana (enrolling)
- CHU de Nice - Hôpital de l'Archet — Nice, Alpes-Maritimes, France (enrolling)
- Cabinet dermatologique gradignan — Gradignan, France (enrolling)
- CHU de la réunion — La Réunion, France (enrolling)
- Ambroise paré — Paris, France (enrolling)
- Cabinet dermatologique — Paris, France (enrolling)
- CH Avicenne - APHP — Paris, France (enrolling)
- CHU de Poitiers — Poitiers, France (enrolling)
- APHP — Paris, Île-de-France Region, France (enrolling)
- Cabinet dermatologique Cenon — Cenon, France
- Cabinet dermatologique privé — Paris, France
Full record on ClinicalTrials.gov
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