Determination of pharmacokinetics and safety of tacrolimus in adolescents with plaque psoriasis MedDRA version: 8.1 Level: LLT Classification code 10037153 Term: Psoriasis
Conditions
Interventions
Product Name: Tacrolimus Cream B 0.1%
Pharmaceutical Form: Cream
INN or Proposed INN: TACROLIMUS
CAS Number: 104987113
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.1
Sponsors
Astelleas Pharma US, Inc.
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to dertermine the pharmacokinetics and safety of tacrolimus in adolescents (= 12 to = 17 years of age) with plaque psoriasis who will be treated topically for 19 days with tacrolimus cream B 0.1%.;Secondary Objective: None;Primary end point(s): Pharmacokinetics based on the following model-independent PK parameters: AUC0-24, AUC0-12, AUC0-t, Cavg, Cmax, Tmax. Safety based on repoprting of Aes, physical examination, vital signs and clinical laboratory evaluations. | — |
Countries
Latvia
Outcome results
None listed