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A Pilot Study of Topical Antiflammin-2 for Psoriasis


N/A
N/A
N/A
Not Enrolling
Both
Psoriasis

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Trial Information

A Pilot Study of Topical Antiflammin-2 for Psoriasis


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.

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.

Type of Study:

Observational

Study Design:

N/A

Authority:

United States: Federal Government

Study ID:

940048

NCT ID:

NCT00001371

Start Date:

December 1993

Completion Date:

December 2000

Related Keywords:

  • Psoriasis
  • Inflammation
  • Lipocortin
  • Phospholipase A-2
  • Skin
  • Uteroglobin
  • Psoriasis
  • Psoriasis

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892