Expired Study
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Boston, Massachusetts 01843


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.


Study summary:

Patients with active plaque psoriasis will be withdrawn from systemic and topical medications.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


Criteria:

Inclusion Criteria: - Active plaque psoriasis at least 10 percent BSA (body surface area) - Age 18-70 Exclusion Criteria: - Abnormalities of calcium metabolism


Study is Available At:


Original ID:

R43 AR46653


NCT ID:

NCT00007306


Secondary ID:

NIAMS-059


Study Acronym:


Brief Title:

Treatment of Psoriasis With Parathyroid Hormone


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:


Overall Contact Information

Official Name:Michael Holick, PhD, MD
Principal Investigator

Study Dates

Start Date:January 2000
Completion Date:April 2005
Verification Date:March 2003
Last Changed Date:January 2, 2007
First Received Date:December 16, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Parathyroid hormone ointment

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:12932245

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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