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

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 30
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CH D'argenteuil
RECRUITING
Argenteuil
CHU de Bordeaux
RECRUITING
Bordeaux
Cabinet Dermatologique Brest 1
NOT_YET_RECRUITING
Brest
Cabinet Dermatologique Brest 2
NOT_YET_RECRUITING
Brest
Cabinet dermatologique Cenon
NOT_YET_RECRUITING
Cenon
Cabinet dermatologique gradignan
NOT_YET_RECRUITING
Gradignan
CHU de la réunion
RECRUITING
La Réunion
CHU de Nantes
RECRUITING
Nantes
CHU de Nice - Hôpital de l'Archet
RECRUITING
Nice
APHP
RECRUITING
Paris
Cabinet dermatologique privé
NOT_YET_RECRUITING
Paris
CH Avicenne - APHP
NOT_YET_RECRUITING
Paris
Hôpital Béclére
NOT_YET_RECRUITING
Paris
chu de Rouen
NOT_YET_RECRUITING
Rouen
Cabinet de dermatologie St Maxime
NOT_YET_RECRUITING
Sainte-maxime
French Guiana
CH de Cayenne 3 Avenue Alexis Blaise, BP6006
RECRUITING
Cayenne
Contact Information
Primary
Thierry Passeron, PhD
passeron.t@chu-nice.fr
+33492036488
Backup
Emmanuelle Pradelli
pradelli.e@chu-nice.fr
+33492036488
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 420
Treatments
Experimental: Drug group
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.
Active_comparator: Doxycycline
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.
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Nice

This content was sourced from clinicaltrials.gov