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ClinicalTrials.gov ID

NCT06447480

Lead Sponsor

Centre Hospitalier Universitaire de NiceOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

420Estimated

Last Update Posted

May 20, 2026Actual

Start Date

Apr 29, 2025Actual

Primary Completion Date

Sep 1, 2026Estimated

Completion Date

Sep 1, 2027Estimated

Official Title

Randomized Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients: ETHNIC Study

Brief Summary

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

• Acne Vulgaris

• ISOtretinoin 5 MG
• Topical cream

Ages Eligible for Study

Child (0-17)Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Centre Hospitalier Universitaire de NiceOTHER

tu-anh.duong@aphp.fr