A Randomised, Multicentre, Investigator-Blind, Parallel-Group Trial to Evaluate the Efficacy and Safety of MC2-01 Cream Compared to Vehicle and Active Comparator in Subjects with Mild-to-Moderate Psoriasis Vulgaris

Drug Delivery SolutionsLtd (Part of MC2 Therapeutics)0 个研究点目标入组 490 人开始时间: 2018年11月23日最近更新: 2021年4月5日

研究概览

暂无简介。

•- provide written informed consent
•- healthy males or non-pregnant females, who are at least 18 years of age
•- clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months duration that involves the body (trunk and/or limbs)
•- mild or moderate disease severity
•- treatment area involving 2-30% of the body
•- negative urine pregnancy test for WOCB and use of contraception
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 416
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•- unstable forms of psoriasis
•- other inflammatory skin disease in the treatment area
•- presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas
•- hypersensitivity to any component of the test product or reference product;
•- history of disorders of calcium metabolism
•- females who are pregnant, breast feeding, or planning a pregnancy
•- systemic treatment with therapies with a possible effect on psoriasis vulgaris within the respective wash out periods prior to inclusion in the study
•- systemic treatments with immunosuppressants and anti-neoplastics during respective wash-out periods
•- use of phototherapy and UV-B radiation
•- use of topical treatments with a possible effect on psoriasis during wash-out period
•- clinical signs of skin infection
•- known Human Immunodeficiency Virus (HIV) infection
•- any chronic or acute medical condition that, in the opinion of the investigator, may pose a risk to the safety of the subject
•- requirement of use or changes of concomitant medication that, in the investigator’s opinion, may affect psoriasis or has the potential for drug-drug interactions, that might cause AEs or interfere with interpretation of results
•- Participation in another clinical trial
•- in the opinion of the investigator, the subject is unlikely to comply with the clinical trial protocol

发起方

Drug Delivery SolutionsLtd (Part of MC2 Therapeutics)