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Study of Topical Calcitriol or Oral Calcitriol in Patients With Psoriasis

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
Overall Status
Withdrawn
CT.gov ID
NCT00004468
Collaborator
Boston University (Other)
0
Enrollment

Study Details

Study Description

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.

  1. Evaluate the long term safety and efficacy of topically administered calcitriol in patients with at least 5% of their body covered with psoriasis.

  2. Compare the topical calcitriol treatment to the oral calcitriol treatment in these patients.

Condition or Disease Intervention/Treatment Phase
N/A

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
Actual Enrollment :
0 participants
Primary Purpose:
Treatment
Study Start Date :
Oct 1, 1998

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    • Boston University

    Investigators

    • Study Chair: Michael F. Holick, Boston University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    ClinicalTrials.gov Identifier:
    NCT00004468
    Other Study ID Numbers:
    • 199/13927
    • BUSM-87-011
    • R01DK043690
    First Posted:
    Oct 19, 1999
    Last Update Posted:
    Mar 2, 2018
    Last Verified:
    Feb 1, 2018
    Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    dermatologic disorders
    psoriasis
    rare disease
    Additional relevant MeSH terms:
    Psoriasis
    Calcitriol

    Study Results

    No Results Posted as of Mar 2, 2018