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临床试验/CTIS2023-507519-36-00
CTIS2023-507519-36-00进行中(未招募)1 期

Randomized clinical trial to compare oral isotretinoin to standard of care in moderate acne skin of color patients

Centre Hospitalier Universitaire De Nice0 个研究点目标入组 420 人开始时间: 2023年11月23日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
420

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
0 至 64(—)
性别
All

入选标准

  • 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

排除标准

  • 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

研究者

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