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	Treatment or Intervention	Phase
Plaque psoriasis	Drug: Parathyroid hormone ointment	Phase I Phase II

Further Study Details: 

Expected Total Enrollment:  40

Patients with active plaque psoriasis will be withdrawn from systemic and topical medications.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

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Abnormalities of calcium metabolism

Massachusetts
      Boston University School of Medicine, Boston,  Massachusetts,  01843,  United States

Study chairs or principal investigators

Michael Holick, PhD, MD,  Principal Investigator

Study ID Numbers:  NIAMS-059; R43 AR46653
Record last reviewed:  March 2003
Last Updated:  October 13, 2004
Record first received:  December 16, 2000
ClinicalTrials.gov Identifier:  NCT00007306
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08