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

Centre Hospitalier Universitaire de Nice

Status and phase: Enrolling; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Topical cream; Drug: ISOtretinoin 5 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT06447480

22-APN-02

Details and patient eligibility

About

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

Enrollment: 420 estimated patients

Sex: All

Ages: 13 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 2 patient groups

Drug group

Experimental group

Description:

Patients will be followed every month for 6 months in the group isotretinoin. Patients will start at the dose of 0.5 mg/kg/d. If tolerance is poor, the dose could be decrease to 0.25mg/d. After 3 months, following the recommendations the dose could be increase up to 1mg/kg/d depending on the efficacy.

Treatment:

Drug: ISOtretinoin 5 MG

Doxycycline

Active Comparator group

Description:

Patients will be followed at 3 and 6 months in the group "standard of care". They will be prescribed topical tretinoin or adapalene once daily (every other day if irritation) with doxycycline or lymecycline 100 mg/d.

Treatment:

Drug: Topical cream