Treatment of Psoriasis With Parathyroid Hormone

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. Identifier: NCT00007306
Recruitment Status : Completed
First Posted : December 18, 2000
Last Update Posted : January 4, 2007
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Brief Summary:
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 or disease Intervention/treatment Phase
Plaque Psoriasis Drug: Parathyroid hormone ointment Phase 1 Phase 2

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Patients with active plaque psoriasis will be withdrawn from systemic and topical medications.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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
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
Study Start Date : January 2000
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones Psoriasis

Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Abnormalities of calcium metabolism

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 identifier (NCT number): NCT00007306

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)
Principal Investigator: Michael Holick, PhD, MD

Publications: Identifier: NCT00007306     History of Changes
Other Study ID Numbers: R43AR046653 ( U.S. NIH Grant/Contract )
First Posted: December 18, 2000    Key Record Dates
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
Topical medications
Calcium metabolism
Skin biopsy

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