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A Pilot Study of Topical Antiflammin-2 for Psoriasis

This study has been completed.

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001371
  Purpose

This study is a pilot trial designed to evaluate topical antiflammin-2, a phospholipase A2 (PLA2) inhibitor, in the treatment of chronic plaque psoriasis. Antiflammin-2 in an ointment base, or the vehicle alone will each be applied four times per day to a single plaque in a randomized, double-blinded fashion.


Condition
Psoriasis

MedlinePlus related topics:   Psoriasis   

U.S. FDA Resources

Study Type:   Observational
Official Title:   A Pilot Study of Topical Antiflammin-2 for Psoriasis

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment:   24
Study Start Date:   December 1993
Estimated Study Completion Date:   December 2000

Detailed Description:

This study is a pilot trial designed to evaluate topical antiflammin-2, a phospholipase A2 (PLA2) inhibitor, in the treatment of chronic plaque psoriasis. Antiflammin-2 in an ointment base, or the vehicle alone will each be applied four times per day to a single plaque in a randomized, double-blinded fashion.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Patients must be age 18 or older.

Patients male or female must use contraception if of childbearing age. No men and women actively attempting to conceive a child during the time of drug testing. No pregnant or nursing women.

Patients must be otherwise healthy, immunocompetent, ambulatory patients with psoriasis who have more than 5 percent of their body surface area involved with the disease or who have localized disabling psoriasis.

Have failed one prior topical treatment regimen including topical cortiscosteroids, coat tar preparations, or ultraviolet light.

An ambulatory performance status of 0,1,2 (ECOG Scale).

Ability to participate in an out -patient study and to provide informed consent.

Creatinine less than 2.0 mg/100ml. Bilirubin less than or equal to 1.5 mg/100ml; prothrombin time less than or equal to 1.3 times control. WBC greater than 3000/mm(3), granulocytes greater than 1500/mm(3), platelets greater than 100,000/mm(3).

No clinically significant cardiac disease.

No patients with previously documented serious infectious diseases such as pneumocystis pneumonia, mycobacterium avium infection, etc. which would suggest clinically evident immunodeficiency.

No systemic treatment for psoriasis (methotrexate, PUVA, UVB, cyclosporine, etc.) and topical treatments (corticosteroids, tar, anthralin, etc.) during the four weeks prior to study entry, and topical treatment during the two weeks prior to study entry.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001371

Locations
United States, Maryland
National Cancer Institute (NCI)    
      Bethesda, Maryland, United States, 20892

Sponsors and Collaborators
  More Information


Study ID Numbers:   940048, 94-C-0048
First Received:   November 3, 1999
Last Updated:   March 3, 2008
ClinicalTrials.gov Identifier:   NCT00001371
Health Authority:   United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Inflammation  
Lipocortin  
Phospholipase A-2  
Skin
Uteroglobin
Psoriasis

Study placed in the following topic categories:
Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous
Inflammation

ClinicalTrials.gov processed this record on December 03, 2008




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