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Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients

Study acronym: ETHNIC
StatusRecruiting
PhasePhase 3
Started2025-04-29
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Sep 1, 2026 → Sep 1, 2027
See other at-risk trials from Centre Hospitalier Universitaire de Nice

Amendment history

2026-10-02
critical
Primary completion pushed: 2026-09-01 → 2027-09-01
Completion pushed: 2027-09-01 → 2028-09-01
2026-05-18
minor
Study Status, Contacts/Locations v5
Start dateestimated 2025-07-01→confirmed 2025-04-29
Study sites16→19
2025-03-24
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start date2025-03-01→2025-07-01
Study sites15→16
2025-01-10
minor
Study Status v3
Start date2024-12-01→2025-03-01
2024-10-14
minor
Study Status v2
Start date2024-09-01→2024-12-01
2024-07-15
minor
Study Identification, Study Status, Arms and Interventions v1
Study title-11 characters
Randomized Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients
2024-06-03
minor
Original filing
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
Trial Details
NCT Number NCT06447480
Lead Sponsor Centre Hospitalier Universitaire de Nice
Conditions Acne Vulgaris
Enrollment 420 participants
Start Date 2025-04-29
Primary Completion 2027-09-01 (estimated)
Study Completion 2028-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-10-01