A Phase 1/2 interventional study of Parathyroid hormone ointment in Plaque Psoriasis, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2007-01-04.
Sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Phase 1/2, Interventional, and Treatment
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Patients with active plaque psoriasis will be withdrawn from systemic and topical medications.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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 40 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is the lead sponsor of 100 studies on the registry; 12 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)