A Phase 1 Open-Label Study of the Pharmacokinetics of Tacrolimus Cream B 0.1% after Twice Daily Topical Administration in Adolescents (= 12 to = 17 Years of Age ) with Psoriasis - Tacrolimus Cream B 0.1% in Adolescents

Astelleas Pharma US, Inc.0 个研究点目标入组 20 人开始时间: 2006年9月29日最近更新: 2012年3月19日

研究概览

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•Subject/Parent or Guardian has provided IRB/IEC- approved written assent (minors) or consent (parents/guardian)
•Subject is = 12 to = 17 years of age
•Subject has a diagnosis of plaque psoriasis and has a Physician's Static Global Assessment Score of = 3
•Body Surface Area (BSA) of plaque psoriasis-covered skin collectively accounts for = 10% BSA, not including the scalp
•Negative pregancy test
•Sexually active females must agree to use contraception/birth control measures while on study and during pre-study washout
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•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

•Subject has genodermatosis that results in a defective epidermal barrier function (e.g., Netherton Syndrom)
•Subject has another skin disorder (including infection) in the treatment area
•Subject has pustular or erythrodermic psoriasis
•Subject has known hypersensitivity to macrolides or any excipient of the drug
•Subject has a chronic condition (e.g. diabetes, hypertension) which is not stable and/ or well controlled
•Subject has a history or presence of malignancy (including skin cancer), immuno-deficiency syndrome, serious active or recurrent infection, or any medical condition or disorder that, in the opinion of the investigator, precludes the subject from participating in the study, or being compliant

发起方

Astelleas Pharma US, Inc.