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Study of Topical Calcitriol or Oral Calcitriol in Patients With Psoriasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004468
First Posted: October 19, 1999
Last Update Posted: June 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Boston University
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Purpose

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.


Condition Intervention
Psoriasis Drug: calcitriol

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment: 500
Study Start Date: October 1998
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004468


Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Boston University
Investigators
Study Chair: Michael F. Holick Boston University
  More Information

Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00004468     History of Changes
Other Study ID Numbers: 199/13927
BUSM-87-011 ( Other Identifier: Boston University School of Medicine )
R01DK043690 ( U.S. NIH Grant/Contract )
First Submitted: October 18, 1999
First Posted: October 19, 1999
Last Update Posted: June 1, 2017
Last Verified: July 2004

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
dermatologic disorders
psoriasis
rare disease

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcitriol
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents