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.
Patients with active plaque psoriasis will be withdrawn from systemic and topical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.
- Active plaque psoriasis at least 10 percent BSA (body surface area)
- Age 18-70
- Abnormalities of calcium metabolism