Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients
ETHNIC
Randomized Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients: ETHNIC Study
1 other identifier
interventional
420
1 country
15
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2025
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2024
CompletedFirst Posted
Study publicly available on registry
June 7, 2024
CompletedStudy Start
First participant enrolled
July 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
March 25, 2025
March 1, 2025
1.2 years
June 3, 2024
March 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Severity of score acne-related pigmentation
To assess the superiority after 6 months of a first line oral isotretinoin treatment of moderate facial acne in skin of color patients compared to the current standard of care on the severity of ARP.
at 6 months
Secondary Outcomes (2)
Quality of life of patient
at 6 months
Number of adverse events
during 6 months
Study Arms (2)
Drug group
EXPERIMENTALPatients 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.
Doxycycline
ACTIVE COMPARATORPatients 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
CHU de Nice - Hôpital de l'Archet
Nice, Alpes-Maritimes, 06200, France
CHU de Bordeaux
Bordeaux, Aquitaine, 33000, France
CHU de Nantes
Nantes, Loire-Atlantique, 44 000, France
chu de Rouen
Rouen, Seine-maritime, 76000, France
Cabinet de dermatologie St Maxime
Sainte-Maxime, Var, 83000, France
CH D'argenteuil
Argenteuil, France
Cabinet Dermatologique Brest 1
Brest, France
Cabinet Dermatologique Brest 2
Brest, France
Cabinet dermatologique Cenon
Cenon, France
Cabinet dermatologique gradignan
Gradignan, France
CHU de la réunion
La Réunion, France
Cabinet dermatologique privé
Paris, France
CH Avicenne - APHP
Paris, France
Hôpital Béclére
Paris, France
APHP
Paris, Île-de-France Region, 75000, France
CH de Cayenne 3 Avenue Alexis Blaise, BP6006
Cayenne, 97306, French Guiana
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thierry Passeron, PhD
CHU de Nice, Service de Dermatologie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2024
First Posted
June 7, 2024
Study Start
July 1, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2027
Last Updated
March 25, 2025
Record last verified: 2025-03