Treatment of Psoriasis With Parathyroid Hormone

This study has been completed.
Sponsor:
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:
NCT00007306
First received: December 16, 2000
Last updated: January 2, 2007
Last verified: March 2003
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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Patients with active plaque psoriasis will be withdrawn from systemic and topical medications.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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00007306

Locations
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 01843
Sponsors and Collaborators
Investigators
Principal Investigator: Michael Holick, PhD, MD
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00007306     History of Changes
Other Study ID Numbers: R43 AR46653, NIAMS-059
Study First Received: December 16, 2000
Last Updated: January 2, 2007
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014