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Randomized clinical trial to compare oral isotretinoin to standard of care in moderate acne skin of color patients
EU CTIS ID: 2023-507519-36-00
What this study is testing
To assess the superiority at M6 of an early treatment of moderate facial acne in skin of color patients of oral isotretinoin compared to the current standard of care on the severity of ARP
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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 β-hCG)
- Breast-feeding patients
- Refusal of effective contraception for women
- Contra-indications to oral isotretinoin, doxycycline, lymecycline, topical adapalene/tretinoin
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.