Placebo-controlled clinical-instrumental assessment of the efficacy of a cosmetic product adjuvant for the amelioration of atopic dermatitis symptoms

IBSA Farmaceutici (Italy)0 个研究点目标入组 40 人开始时间: 2020年4月24日最近更新: 2020年5月11日

适应症

试验速览

暂无简介。

•1. Male or female subjects, aged 18 years or older at the screening visit
•2. Caucasian ethnicity
•3. Subjects with a diagnosis of AD for at least 6 months prior to Day 1 visit
•4. Subjects with basal SCORAD between 25 and 40
•5. Adequate rest period between two similar studies
•6. Willingness to not use products likely to interfere with the product to be tested
•7. Willingness to not use, during all the study period, face creams other than the products supplied
•8. Subject of childbearing potential is under effective contraception (oral/not oral); not expected to be changed during the study period
•9. Subject informed about the study procedures and having signed an informed consent form

•1. Subject does not meet the inclusion criteria above
•2. Pregnant or breastfeeding women
•3. Subject with a history of any confounding inflammatory skin diseases or any other skin disease, e.g., psoriasis, rosacea, erythroderma or ichthyosis, that could interfere with the evaluation of AD
•4. Subject with spontaneously improving or rapidly deteriorating AD
•5. Subject with active allergic contact dermatitis or other non-atopic forms of dermatitis
•6. Subject with acute infections
•7. Use within 4 weeks prior to baseline (Day 1) of oral or intravenous corticosteroids, 8. UVA/UVB therapy, PUVA (psoralen plus ultraviolet A) therapy, tanning booths, non-prescription UV light sources, immunomodulators or immunosuppressive therapies, 9. interferon, or cytotoxic drugs
•8. Use within 1 week prior to baseline (Day 1) of antihistamines, topical antibiotics, topical corticosteroids, topical calcineurin inhibitors or other topical drug products used for treating AD
•9. Use within 24 hours prior to baseline (Day 1) of any topical product (e.g., sunscreens, lotions, creams) in the areas to be treated

发起方

IBSA Farmaceutici (Italy)