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Study of Topical Calcitriol or Oral Calcitriol in Patients With Psoriasis

This study has been completed.

Sponsors and Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Boston University
Information provided by: Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier: NCT00004468
  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

MedlinePlus related topics:   Psoriasis   

Drug Information available for:   Calcitriol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Safety/Efficacy Study

Further study details as provided by Office of Rare Diseases (ORD):

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
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004468

Sponsors and Collaborators

Investigators
Study Chair:     Michael F. Holick     Boston University    
  More Information


Study ID Numbers:   199/13927, BUSM-87-11, BUSM-87-011
First Received:   October 18, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00004468
Health Authority:   United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
dermatologic disorders  
psoriasis  
rare disease  

Study placed in the following topic categories:
Skin Diseases
Psoriasis
Rare Diseases
Skin Diseases, Papulosquamous
Calcitriol

Additional relevant MeSH terms:
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Growth Substances
Vitamins
Calcium Channel Agonists
Physiological Effects of Drugs
Vasoconstrictor Agents
Bone Density Conservation Agents
Cardiovascular Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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