STA-21 Topical Efficacy on Psoriasis

Kochi University8 enrolled

Overview

The clinical assessment of patients with plaque-type psoriasis is performed by open, intrapatient comparison of 0.2% STA-21 with vehicle(Vaseline) alone within a 2 week period.

Two discrete psoriatic lesions with a similar size (approximately coin-sized) and clinical severity are selected in each patient. Clinical assessment of psoriatic lesion severity is performed at the baseline and at 1 and 2 (end of treatment) using the scores of erythema, induration, scaling on a scale of 0-4 by two observers. Since STA-21 inhibits Stat3 activation, which is essential for disease activity of psoriasis, topical application of 0.2% STA-21 in Vaseline should improve psoriasis in two weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Psoriasis

Interventions

Topical application of STA-21 ointment for treatment of psoriasisDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A history of plaque psoriasis for a minimum of 2 years. * In good general health, as evidenced by blood, renal function, and liver function tests conducted before commencing the study. * Patients of childbearing age who agreed to continue using birth control for the duration of the study. * Men or women between 20 and 80 years old. Exclusion Criteria: * Chronic plaque psoriasis involving \>40% of the body surface. * Pustular or generalized erythrodermic psoriasis. * Use of medications that might affect the psoriasis during the study * Systemic therapy for psoriasis within 60 d of baseline. * UV therapy within 21 d of baseline. * Topical therapy within 14 d of baseline. * Positive for HIV, hepatitis B, or hepatitis C. * Clinically significant laboratory abnormality in blood, renal function, or liver function. * Lactating, pregnant, or planning to become pregnant. * Participation in another clinical trial in the last 30 d. * Unwillingness to comply with the study protocol. * Any other condition that in the opinion of the investigators could compromise the study.

Locations (1)

Department of Dermatology, Kochi Medical School, Kochi University

Nankoku, Japan

Outcomes

Primary Outcomes

Erythema, induration and scaling are scored on a scale of 0 to4 (O indicating none, 4 very severe)

Time frame: 2 weeks

Data from ClinicalTrials.gov

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