A Pilot Study of Topical Antiflammin-2 for Psoriasis

NCT ID: NCT00001371

Last Updated: 2008-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

1993-12-31

Study Completion Date

2000-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psoriasis

Eligibility Criteria

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Inclusion 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Locations

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National Cancer Institute (NCI)

Bethesda, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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94-C-0048

Identifier Type: -

Identifier Source: secondary_id

940048

Identifier Type: -

Identifier Source: org_study_id

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