Psoriasis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGTopical application of STA-21 ointment for treatment of psoriasis
Sponsors
Kochi University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Erythema, induration and scaling are scored on a scale of 0 to4 (O indicating none, 4 very severe) | 2 weeks |
Countries
Japan
Outcome results
None listed