Psoriasis Vulgaris Clinical Trial
Official title:
Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris
The purpose of this study is to evaluate the safety and efficacy of 4 weeks of TACLONEX ointment in adolescent patients with psoriasis vulgaris.
TACLONEX ointment has marketing approval in many countries for the treatment of psoriasis
vulgaris in adults. No studies have been conducted in patients less than 18 years of age.
However, about 25% of affected individuals are diagnosed between 10 and 19 years of age,
hence psoriasis is also prevalent in the adolescent age group (12-17 years).
All patients will receive TACLONEX. To evaluate the safety of TACLONEX ointment, all adverse
events will be recorded. In addition, any systemic absorption of the active components,
betamethasone dipropionate and calcipotriene, will be evaluated by assessing adrenal
function (using CORTROSYN™ test) and calcium metabolism (by measuring serum calcium and the
urinary calcium:creatinine ratio), respectively.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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