EUCTR2018-000685-12-CZ进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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