Study of Topical Calcitriol or Oral Calcitriol in Patients With Psoriasis
calcitriol
Pathologic Processes+5
+ Pathological Conditions, Signs and Symptoms
+ Skin and Connective Tissue Diseases
Treatment Study
Summary
Study start date: October 1, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Psoriasis covering at least 5% of body --Prior/Concurrent Therapy-- At least 30 days since prior systemic therapy for psoriasis At least 14 days since prior topical therapy for psoriasis No other concurrent treatment for psoriasis for the first 2-4 months of study No calcium supplement greater than 1,000 mg per day --Patient Characteristics-- No hypercalcemia No hypercalciuria Not pregnant Effective contraception required of all fertile patients