A Multicentre, Open-label, Single-group Maximal Use Trial, Evaluating the Safety and Pharmacokinetic Profile of the Active Ingredients and their Metabolites after application of MC2-01 Cream in Adolescent Subjects (age 12 to 16 years, 11 months) with Extensive Psoriasis Vulgaris

MC2 Therapeutics Ltd0 个研究点目标入组 30 人开始时间: 2018年5月22日最近更新: 2021年4月5日

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•The parent(s), or legal guardian(s)have provided written informed consent.
•The subject has provided written assent to the trial.
•Healthy males or non-pregnant females, who are between 12 to 16 years, 11-month-old.
•Clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months, with or without scalp
•Treatment area between 10% and 30% of the BSA on the body and scalp
•At least moderate severity on the treatment area
•Normal HPA axis function
•Serum albumin-corrected calcium below the upper reference limit at SV2
•Negative urine pregnancy test for WOCP and use of a highly effective method of contraception
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 30
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Unstable forms of psoriasis
•Other inflammatory skin disease in the treatment area
•Presence of pigmentation or extensive scarring in the treatment area
•Use of phototherapy within 4 weeks prior to inclusion
•Current or past history of disorders of calcium metabolism
•Oral calcium supplements, vitamin D supplements, bisphosphonates or calcitonin
•Strong systemic cytochrome P450 3A4 (CYP 3A4) inhibitors and inducers
•Use of topical treatments for Psoriasis 2 weeks prior to inclusion
•Systemic treatment with biological therapies for Psoriasis
•Use of systemic medication that suppresses the immune system
•Use of life vaccines
•Known allergic asthma or serious allergies
•Skin infections
•Known human immunodeficiency virus (HIV) infection
•Known or suspected of hypersensitivity to any component of the test product or reference
•Any chronic or acute medical condition that, in the opinion of the investigator, may pose a risk to the safety of the subject
•Females who are pregnant, breast feeding, or planning a pregnancy
•Participation in another clinical trial or received an IP or non-marketed drug substance
•within 30 days
•Previously enrolled in this trial
•Subject is unlikely to comply with the clinical trial protocol in the opinion of the investigator

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