NCT00007306

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2000

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2000

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
Last Updated

January 4, 2007

Status Verified

March 1, 2003

First QC Date

December 16, 2000

Last Update Submit

January 2, 2007

Conditions

Plaque Psoriasis

Keywords

Parathyroid hormonePsoriasisLesionsTopical medicationsOintmentCalcium metabolismSkin biopsy

Interventions

Parathyroid hormone ointmentDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Abnormalities of calcium metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University School of Medicine

Boston, Massachusetts, 01843, United States

Location

Related 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. doi: 10.1046/j.1365-2133.2003.05437.x.

    PMID: 12932245BACKGROUND

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Michael Holick, PhD, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

December 16, 2000

First Posted

December 18, 2000

Study Start

January 1, 2000

Study Completion

April 1, 2005

Last Updated

January 4, 2007

Record last verified: 2003-03

Locations

US(1)