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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · Jun 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how effective an oral medication called isotretinoin is in treating moderate acne in patients with darker skin types (Fitzpatrick skin types IV, V, and VI) compared to the current standard treatment, which usually involves oral antibiotics like doxycycline. Acne can significantly impact a person's life, and many treatments have not been tested specifically on individuals with darker skin tones. This trial aims to see if starting with isotretinoin instead of antibiotics can better reduce acne and related skin discoloration, known as acne-related pigmentation.

To participate, individuals must be between 13 and 30 years old, have moderate acne as defined by specific guidelines, and be able to take selfies with a smartphone. Participants need to provide consent and have health coverage in France. Those with severe or mild acne, a history of certain treatments, or specific health conditions will not be eligible. If you join the study, you'll receive either isotretinoin or standard care and will be monitored for changes in your acne and skin condition over six months. This trial is important because it seeks to improve treatment options for young people with darker skin who suffer from acne.

Gender

ALL

Eligibility criteria

• 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