- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00007306
Treatment of Psoriasis With Parathyroid Hormone
Evaluation of the Therapeutic Efficacy & Safety of Topical Administration of Parathyroid Hormone (PTH) in Psoriasis
Study Overview
Status
Conditions
Intervention / Treatment
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Patients with active plaque psoriasis will be withdrawn from systemic and topical medications.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.
Study Type
Enrollment
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 01843
- Boston University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Active plaque psoriasis at least 10 percent BSA (body surface area)
- Age 18-70
Exclusion Criteria:
- Abnormalities of calcium metabolism
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Collaborators and Investigators
Investigators
- Principal Investigator: Michael Holick, PhD, MD
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R43AR046653 (U.S. NIH Grant/Contract)
- NIAMS-059
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Plaque Psoriasis
-
UCB Biopharma SRLRecruitingModerate Chronic Plaque Psoriasis | Severe Chronic Plaque Psoriasis | Mixed Guttate/Plaque PsoriasisUnited States, Canada, Puerto Rico
-
Idera Pharmaceuticals, Inc.CompletedModerate to Severe Plaque Psoriasis | Actively Extending Plaque PsoriasisUnited States
-
Fresenius Kabi SwissBioSim GmbHMerck KGaA, Darmstadt, GermanyCompletedPsoriasis | Moderate to Severe Plaque Psoriasis | Plaque Type PsoriasisUnited States, Canada, Czechia, Hungary, Russian Federation, Bulgaria, Mexico, United Kingdom, Poland, Germany, Estonia, France
-
UCB Biopharma SRLCompletedModerate to Severe Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Australia, Canada, Germany, Hungary, Korea, Republic of, Poland, Russian Federation, Taiwan
-
UCB Biopharma SRLCompletedModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Australia, Belgium, Canada, Germany, Hungary, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Taiwan, United Kingdom
-
UCB Biopharma SRLCompletedModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Australia, Belgium, Canada, France, Germany, Netherlands, Poland, Spain, Turkey, United Kingdom
-
Biocon Biologics Inc.MEDA Pharma GmbH & Co. KG; Mylan Inc.; IQVIA Pvt. LtdCompletedHulio Interchangeability to Humira®, Comparing Pharmacokinetics, Efficacy, Safety and ImmunogenicityModerate Chronic Plaque Psoriasis | Severe Chronic Plaque PsoriasisBulgaria, Czechia, Estonia, Poland
-
UCB Biopharma SRLCompletedModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Canada
-
UCB Biopharma SRLActive, not recruitingModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisChina
-
AmgenCompletedPsoriasis-Type Psoriasis | Plaque-Type PsoriasisUnited States
Clinical Trials on Parathyroid hormone ointment
-
HaEmek Medical Center, IsraelWithdrawnHypercalcemia | Parathyroid AdenomaIsrael
-
University of PittsburghNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...Completed
-
The Emmes Company, LLCNational Heart, Lung, and Blood Institute (NHLBI)TerminatedStudy of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated DonorLymphoma | Hodgkin Disease | Myelofibrosis | Anemia, Aplastic | Leukemia, Lymphocytic, Acute | Leukemia, Myelocytic, Acute | Leukemia, Myeloid, Chronic | Leukemia, Lymphocytic, ChronicUnited States
-
Postgraduate Institute of Medical Education and...CompletedDiabetic Neuropathic ArthropathyIndia
-
National Institute of Diabetes and Digestive and...Completed
-
University of PittsburghNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Withdrawn
-
University of PittsburghNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedHyperparathyroidism | Osteoporosis | Humoral Hypercalcemia of MalignancyUnited States
-
University of PittsburghNational Institutes of Health (NIH); Department of Health and Human ServicesCompletedOsteoporosis | Osteoporosis, PostmenopausalUnited States
-
Columbia UniversityCompletedOsteoporosisUnited States
-
Tongji HospitalUnknownParathyroid Autologous TransplantationChina