Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06447480

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

13 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Nice - Hôpital de l'Archet, Nice, Alpes-Maritimes, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ISOtretinoin 5 MG

Drug

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 Cream

Drug

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 outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuelle Pradelli

CONTACT

[email protected]

+33492036488

Thierry Passeron, PhD

CONTACT

[email protected]

+33492036488

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: ETHNIC

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 7, 2024
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.