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

RecruitingPhase 3Ages 13 Years - 30 YearsAllCentre Hospitalier Universitaire de Nice
NCT06447480 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • ISOtretinoin 5 MG
  • Topical cream
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Where

19 sites
CHU de Nice - Hôpital de l'Archet
Nice, France
CHU de Bordeaux
Bordeaux, France
CHU de Nantes
Nantes, France
chu de Rouen
Rouen, France
Cabinet de dermatologie St Maxime
Sainte-Maxime, France
CH D'argenteuil
Argenteuil, France
Cabinet Dermatologique Brest 1
Brest, France
Cabinet Dermatologique Brest 2
Brest, France

…and 11 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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