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Treatment of Psoriasis With Parathyroid Hormone

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00007306
Enrollment
40
Registered
2000-12-18
Start date
2000-01-31
Completion date
2005-04-30
Last updated
2007-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

Keywords

Parathyroid hormone, Psoriasis, Lesions, Topical medications, Ointment, Calcium metabolism, Skin biopsy

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.

Detailed description

Patients with active plaque psoriasis will be withdrawn from systemic and topical medications.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

Interventions

DRUGParathyroid hormone ointment

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Abnormalities of calcium metabolism

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026