Study of Topical Calcitriol or Oral Calcitriol in Patients With Psoriasis
OBJECTIVES: I. Evaluate the long term safety and efficacy of orally administered calcitriol in patients with at least 5% of their body covered with psoriasis.
II. Evaluate the long term safety and efficacy of topically administered calcitriol in patients with at least 5% of their body covered with psoriasis.
III. Compare the topical calcitriol treatment to the oral calcitriol treatment in these patients.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
|Study Start Date:||October 1998|
PROTOCOL OUTLINE: This is a part placebo-controlled (arm I) study. Patients either apply topical petrolatum (Vaseline) with calcitriol (vitamin D3) on a psoriatic lesion daily and petrolatum only on an other similar lesion daily to serve as a control (arm I) or receive oral calcitriol nightly (arm II).
Arm I patients continue treatment for at least 2 months. At the end of 2 months of topical treatment, one biopsy is taken of the lesion treated with calcitriol, one biopsy of the lesion treated with petrolatum alone, and one biopsy of skin unaffected by psoriasis. Lesions are also photographed prior to therapy, 2-4 weeks during therapy for the first two months, then once every 1-3 months, and then once at end of treatment.
Arm II patients increase dosage of oral calcitriol every 2 weeks up to a maximum dosage daily in the absence of adverse effects (high urinary calcium or serum calcium levels). Patients continue treatment for at least 1 month. Lesions are photographed prior to therapy, 2-4 weeks during therapy, and then once at end of treatment.
|Study Chair:||Michael F. Holick||Boston University|