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

May 18, 2026 updated by: Centre Hospitalier Universitaire de Nice

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

420

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Argenteuil, France
      • Brest, France
        • Recruiting
        • Cabinet Dermatologique Brest 1
        • Contact:
        • Sub-Investigator:
          • Nicole Jouan, Ph
      • Brest, France
        • Recruiting
        • Cabinet Dermatologique Brest 2
        • Contact:
        • Sub-Investigator:
          • Martine Schollhammer, Ph
      • Cenon, France
        • Not yet recruiting
        • Cabinet dermatologique Cenon
        • Contact:
        • Sub-Investigator:
          • Jean-Michel Amici, Ph
      • Gradignan, France
        • Recruiting
        • Cabinet dermatologique gradignan
        • Contact:
        • Sub-Investigator:
          • Sandra Ly, Ph
      • La Réunion, France
        • Recruiting
        • CHU de la réunion
        • Contact:
        • Sub-Investigator:
          • antoine bertolotti, PhD
      • Paris, France
        • Not yet recruiting
        • Cabinet dermatologique privé
        • Contact:
        • Sub-Investigator:
          • Pierre Schneider, Ph
      • Paris, France
        • Recruiting
        • Ambroise paré
        • Contact:
        • Sub-Investigator:
          • Tu-Anh Duong, Ph
      • Paris, France
        • Recruiting
        • Cabinet dermatologique
        • Principal Investigator:
          • Christelle Comte
        • Contact:
      • Paris, France
        • Recruiting
        • CH Avicenne - APHP
        • Contact:
        • Sub-Investigator:
          • Gérôme Bohelay, Ph
      • Poitiers, France
        • Recruiting
        • CHU De Poitiers
        • Contact:
        • Principal Investigator:
          • Da Hee Pitaud
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06200
        • Recruiting
        • CHU de Nice - Hôpital de l'Archet
        • Contact:
        • Principal Investigator:
          • Thierry Passeron, PhD
    • Aquitaine
      • Bordeaux, Aquitaine, France, 33000
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44 000
    • Seine-maritime
      • Rouen, Seine-maritime, France, 76000
    • Var
      • Sainte-Maxime, Var, France, 83000
        • Recruiting
        • Cabinet de dermatologie St Maxime
        • Contact:
        • Sub-Investigator:
          • Marc Reverte, Ph
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75000
        • Recruiting
        • APHP
        • Contact:
        • Sub-Investigator:
          • Coralie LHEURE, PhD
  • French Guiana
      • Cayenne, French Guiana, 97306
      • Fort-de France, French Guiana
        • Recruiting
        • Cabinet de dermatologie DERMACLINIC 972
        • Contact:
        • Principal Investigator:
          • Emilie Baubion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of score acne-related pigmentation
Time Frame: at 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life of patient
Time Frame: at 6 months
Quality of life will be evaluated with the Acne-specific Quality of Life questionnaire (Acne-QoL)
at 6 months
Number of adverse events
Time Frame: during 6 months
A special focus on scars will be performed using an Investigator Global Assessment score (0 no scar, 1 mild scarring, 2 moderate, 3 severe) over the study period.
during 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Thierry Passeron, PhD, CHU de Nice, Service de Dermatologie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-APN-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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