Assessment of the efficacy of a 6-week randomized, controlled half-face treatment with topical formulae containing 4% ER2412 compared to placebo in healthy volunteers with oily skin.

OREAL RESEARCH0 个研究点目标入组 37 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 37

研究概览入排标准研究者记录与标识符相似试验

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

入选标准

•Healthy male volunteers, aged 18 â?? 40 years
•-Skin phototype II -V (Fitzpatrick)
•-Presenting an oily skin appearance on the face (sebum rate >70 Âµg/cm2 30 min after degreasing on the forehead right and left)
•-Acne prone subjects showing the presence of facial acne (grade 2-7 in the attached Leeds acne grade - Appendix 1), presenting at least 15 inflammatory lesions and at least 25 non-inflammatory lesions on the face
•-Able to give written informed consent and to comply with the requirements of the study

排除标准

•-Female subjects
•-Known hypersensitivity to any of the study drugs or constituents
•-Skin disorders affecting the study area which, in the supervisorâ??s / designatorâ??s judgment, would interfere with grading / assessment of skin response (e.g. severe acne grade 8-9 in the Leeds Acne Grade, rosacea, eczema, seborrhoeic dermatitis, psoriasis, disorders of pigmentation, etc â?¦)
•-Use of systemic retinoids within the 6 months prior to participation in the study, and during the study
•-Any topical or systemic treatment that could interfere with the study treatments/assessments (topical benzoyl peroxide and other antiacne or antiseborreic products, antibiotics, corticosteroids, anti-inflammatory drugsâ?¦) within the last 4 weeks prior to participation in the study, and during the study
•-Undergone a facial resurfacing procedure, i.e., chemical peel, laser resurfacing, dermabrasion, within the 6 months prior to participation in the study, and during the study
•-Any surgical treatment on the test areas
•-Subject reported or planning to sun-bath or to overexpose to UV-light (mountains sports, phototherapy, tanning salon useâ?¦) for aesthetic or therapeutic reason the month before the study start or during the study
•-Current use of immunosuppressive drugs and/or an organ transplant
•-Insulin-dependent diabetes
•-Currently receiving allergy injections, final injection within the last week, or expecting to begin injections during the course of the study
•-Immune deficiency or autoimmune disease
•-Subjects with clinically significant dermographism or generalized skin disorders that could compromise evaluation of skin reactions
•-Vaccination during the three weeks preceding the study or intention to be vaccinated during the course of the study
•-A condition or medication which, in the investigatorâ??s judgment, makes the subject ineligible or places the subject at undue risk
•-Febrile disease in the three days preceding the study
•-Any significant medical condition that would interfere in the participation in the trial
•-Participation in a clinical trial up to 1 month prior to inclusion

研究者

发起方

OREAL RESEARCH

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