Treatment of Psoriasis With Parathyroid Hormone

Plaque Psoriasis Clinical Trial

Official title:

Evaluation of the Therapeutic Efficacy & Safety of Topical Administration of Parathyroid Hormone (PTH) in Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00007306
• Other study ID #: R43AR046653
• Secondary ID: NIAMS-059
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 16, 2000
• Last updated: January 2, 2007
• Start date: January 2000
• Est. completion date: April 2005

Study information

• Verified date: March 2003
• Source: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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Patients with active plaque psoriasis will be withdrawn from systemic and topical medications.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Active plaque psoriasis at least 10 percent BSA (body surface area)

• Age 18-70

Exclusion Criteria:

• Abnormalities of calcium metabolism

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Parathyroid hormone ointment

Locations

Country	Name	City	State
United States	Boston University School of Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Holick MF, Chimeh FN, Ray S. Topical PTH (1-34) is a novel, safe and effective treatment for psoriasis: a randomized self-controlled trial and an open trial. Br J Dermatol. 2003 Aug;149(2):370-6. — View Citation