Assessment of the efficacy of randomized, controlled treatment with topical papuduo and papulex compared to its placebo in healthy volunteers with acne prone skin

SINCLAIR PHARMACEUTICALS LTD0 个研究点目标入组 87 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Healthy male or female subject aged between 14-40 years old,
•Fitzpatrick scale IIâ??V phototype (Fitzpatrick classification),
•The subject presenting mild to moderate (score of 5â??22) acne graded according to the Modified Global Acne Grading System (GAGS),
•If the subject is a female of childbearing age using a reliable mean of contraception(for at least one month before the beginning of the study, and throughout the study) or menopausal women (absence of menstrual periods for one year or more),
•Subject who has given freely and expressly his or her informed consent and who is cooperative and aware of the necessity and duration of the controls so that perfect adhesion to the protocol can be expected,
•Subject who is able to read and understand documents transmitted (information sheet and consent form),
•Subject with an official domicile,
•Subject who accepts not to apply cosmetic products other than those they usually applied and at their usual frequency of application,
•Subject with health insurance and/or social security (according to local legislation).

•Female of childbearing potential with a positive urine pregnancy test on the screening date (test performed two weeks before inclusion, at the baseline, at D28 and D56) or if the subject is nursing or doesnâ??t have an effective method of contraception,
•Any significant skin pathology in the test areas, like rosacea, severe acne, eczema.
•Known hypersensitivity to any of the study drugs or constituents,
•Any topical or systemic treatment that could interfere with the study treatments/assessments (antibiotics, corticosteroids, retinoids) and anti-inflammatory drugs for 5 consecutive days) within the last 4 weeks prior to participation in the study, and during the study,
•Any physical treatment on the test areas (laser, peel, dermabrasion,..).
•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,
•Any significant medical condition that would interfere in the participation in the study,
•Subjects who have been deprived of their freedom by administrative or legal decision or who are under guardianship,
•Unable to be contacted by phone in case of emergency,
•Having participated within the 30 days before inclusion or currently participating in another clinical study.

发起方

SINCLAIR PHARMACEUTICALS LTD