Randomized clinical trial to compare oral isotretinoin to standard of care in moderate acne skin of color patients
- Conditions
- AcneMedDRA version: 20.0Level: PTClassification code: 10000496Term: Acne Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- CTIS2023-507519-36-00
- Lead Sponsor
- Centre Hospitalier Universitaire De Nice
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 420
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
Mild and severe acne (ECLA grading : French recommendations) (https://document.sfdermato.org/groupe/centre-de-preuves/label-recommandations-acne-post-college.pdf), Vulnerable people: adult under guardianship or deprived of freedom, 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 ß-hCG), Breast-feeding patients, Refusal of effective contraception for women, Contra-indications to oral isotretinoin, doxycycline, lymecycline, topical adapalene/tretinoin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method