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Treatment of Psoriasis With Parathyroid Hormone

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00007306
First Posted: December 18, 2000
Last Update Posted: January 4, 2007
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.
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  Purpose
This is a clinical study in two phases. The first phase compares the effect of an ointment containing parathyroid hormone (PTH) with the effect of a placebo ointment (inactive ointment without PTH) on psoriasis lesions. Neither the study participants nor the researchers will know who is receiving PTH ointment and who is receiving placebo until the end of this first study phase. The second phase is a study of the PTH ointment on large areas of psoriasis to find out how long the effects last.

Condition Intervention Phase
Plaque Psoriasis Drug: Parathyroid hormone ointment Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Evaluation of the Therapeutic Efficacy & Safety of Topical Administration of Parathyroid Hormone (PTH) in Psoriasis

Resource links provided by NLM:


Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Estimated Enrollment: 40
Study Start Date: January 2000
Estimated Study Completion Date: April 2005
Detailed Description:

Patients with active plaque psoriasis will be withdrawn from systemic and topical medications. After washout, we will select active psoriatic lesions of at least 25 square cm in size to receive either placebo ointment or a proprietary ointment containing PTH for 8 weeks. We will see the patients every 2 weeks. We will evaluate the lesions by examination and digital photography at each visit and measure parameters of calcium metabolism periodically during the 8 weeks.

At the conclusion of the 8 weeks, we will obtain punch biopsies from the treated lesions and from one lesion without treatment. If the patients elect, we will transition them into an open label trial with the PTH ointment including up to 1000 square cm of psoriatic lesions and monitor them for duration of effect and changes in parameters of calcium metabolism.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Active plaque psoriasis at least 10 percent BSA (body surface area)
  • Age 18-70

Exclusion Criteria:

  • Abnormalities of calcium metabolism
  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): NCT00007306


Locations
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 01843
Sponsors and Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Michael Holick, PhD, MD
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00007306     History of Changes
Other Study ID Numbers: R43AR046653 ( U.S. NIH Grant/Contract )
NIAMS-059
First Submitted: December 16, 2000
First Posted: December 18, 2000
Last Update Posted: January 4, 2007
Last Verified: March 2003

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Parathyroid hormone
Psoriasis
Lesions
Topical medications
Ointment
Calcium metabolism
Skin biopsy

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs