EUCTR2006-002738-39-LV
Active, not recruiting
Not Applicable
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 sites20 target enrollmentSeptember 29, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Astelleas Pharma US, Inc.
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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