Comparing Isotretinoin to Standard Care for Moderate Acne in Skin of Color

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of oral isotretinoin compared to standard care in treating moderate acne in patients with skin types IV to VI, which are often underrepresented in clinical research. The study focuses on individuals aged 13 to 30 who experience moderate acne, characterized by specific lesions and associated pigmentation issues. Participants will receive isotretinoin and topical treatments while their progress will be monitored through selfies taken with their cell phones. The trial seeks to address the unique challenges faced by patients of color in managing acne and its effects on quality of life.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU de Nice - Hôpital de l'Archet
  Nice, Alpes-Maritimes, France Recruiting
• CHU de Bordeaux
  Bordeaux, Aquitaine, France Recruiting
• CHU de Nantes
  Nantes, Loire-Atlantique, France Recruiting
• chu de Rouen
  Rouen, Seine-maritime, France Recruiting
• Cabinet de dermatologie St Maxime
  Sainte-Maxime, Var, France Recruiting
• CH D'argenteuil
  Argenteuil, France Recruiting

Study contacts

• Principal investigator: Thierry Passeron, PhD — CHU de Nice, Service de Dermatologie
• Study coordinator: Thierry Passeron, PhD
• Email: passeron.t@chu-nice.fr
• Phone: +33492036488

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.