Study of Topical Calcitriol or Oral Calcitriol in Patients With Psoriasis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
Exclusion Criteria
- Not provided
Arms & Interventions
Untitled Study
Intervention: calcitriol (Drug)