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

Active, not recruiting

• Conditions: Determination of pharmacokinetics and safety of tacrolimus in adolescents with plaque psoriasis; MedDRA version: 8.1Level: LLTClassification code 10037153Term: Psoriasis

• Registration Number: EUCTR2006-002738-39-LV
• Lead Sponsor: Astelleas Pharma US, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified