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Recruiting NCT06447480

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

Phase III Interventional Acne Vulgaris

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ISOtretinoin 5 MG, Topical cream.
Who it may be relevant to
Registry conditions: Acne Vulgaris. Basic parameters: 13 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France, French Guiana
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug ISOtretinoin 5 MG
    The dose is usually of 0.5 mg/kg/d. If tolerance is poor, the dose of isotretinoin can be decreased to 0.25 mg/kg/d. After 3 months of treatment, a clinical evaluation is performed. The dose of isotretinoin can be increased up to 1 mg/kg/d depending on the efficacy (ECLA graded as moderated or severe) and tolerance. A total cumulative dose between 120 to 150 mg/kg is recommended.
  • Drug Topical cream
    Topical retinoic acid (Effederm®) or adapalene cream (Differine®), associated during the 3 first months with doxycycline or lymecycline 100 mg/d. After 3 months, the efficacy is assessed. If acne improved, oral antibiotics are stopped and only the topical treatment is continued. If the ECLA is graded as moderated or severe, isotretinoin should be introduced.

Primary outcome measures

  • Severity of score acne-related pigmentation [Time frame: at 6 months]
Secondary outcome measures (2)
  • Quality of life of patient [Time frame: at 6 months]
  • Number of adverse events [Time frame: during 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 17 centers
  • CHU de Nice - Hôpital de l'Archet — Nice
  • CHU de Bordeaux — Bordeaux
  • CHU de Nantes — Nantes
  • chu de Rouen — Rouen
  • Cabinet de dermatologie St Maxime — Sainte-Maxime
  • CH D'argenteuil — Argenteuil
  • Cabinet Dermatologique Brest 1 — Brest
  • Cabinet Dermatologique Brest 2 — Brest
  • … and 9 more centers
French Guiana · 2 centers
  • CH de Cayenne 3 Avenue Alexis Blaise, BP6006 — Cayenne
  • Cabinet de dermatologie DERMACLINIC 972 — Fort-de France

Identifiers

NCT: NCT06447480 · 22-APN-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗