Clinical trial NCT06447480: Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients
Official title: Randomized Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients: ETHNIC Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 420
Sex: ALL
Minimum age (years): 13
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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 outcomes:
measure: Severity of score acne-related pigmentation
timeFrame: at 6 months
Secondary outcomes:
measure: Quality of life of patient
timeFrame: at 6 months
measure: Number of adverse events
timeFrame: during 6 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - Hôpital de l'Archet
state: Alpes-Maritimes
city: Bordeaux
country: France
facility: CHU de Bordeaux
state: Aquitaine
city: Paris
country: France
facility: APHP
state: Ile De France
city: Nantes
country: France
facility: CHU de Nantes
state: Loire-Atlantique
city: Rouen
country: France
facility: chu de Rouen
state: Seine-maritime
city: Sainte-Maxime
country: France
facility: Cabinet de dermatologie St Maxime
state: Var
city: Argenteuil
country: France
facility: CH D'argenteuil
city: Brest
country: France
facility: Cabinet Dermatologique Brest 1
city: Brest
country: France
facility: Cabinet Dermatologique Brest 2
city: Cenon
country: France
facility: Cabinet dermatologique Cenon
city: Gradignan
country: France
facility: Cabinet dermatologique gradignan
city: La Réunion
country: France
facility: CHU de la réunion
city: Paris
country: France
facility: Cabinet dermatologique privé
city: Paris
country: France
facility: CH Avicenne - APHP
city: Paris
country: France
facility: Hôpital Béclére
city: Cayenne
country: French Guiana
facility: CH de Cayenne 3 Avenue Alexis Blaise, BP6006
Study officials:
affiliation: CHU de Nice, Service de Dermatologie
name: Thierry Passeron, PhD
role: PRINCIPAL_INVESTIGATOR
References: