Clinical trial NCT01047943: STA-21 Topical Efficacy on Psoriasis
Official title: Intrapatient Comparison Study of Efficacy of STA-21 Ointment on Psoriatic Skin Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Psoriasis
Lead sponsor: Kochi University
Sponsor class: OTHER
First posted: 2010-01-13
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Erythema, induration and scaling are scored on a scale of 0 to4 (O indicating none, 4 very severe)
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nankoku
country: Japan
facility: Department of Dermatology, Kochi Medical School, Kochi University
Study officials:
affiliation: Department of Dermatology, Kochi Medical School, Kochi University
name: Shigetoshi Sano, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miyoshi K, Takaishi M, Nakajima K, Ikeda M, Kanda T, Tarutani M, Iiyama T, Asao N, DiGiovanni J, Sano S. Stat3 as a therapeutic target for the treatment of psoriasis: a clinical feasibility study with STA-21, a Stat3 inhibitor. J Invest Dermatol. 2011 Jan;131(1):108-17. doi: 10.1038/jid.2010.255. Epub 2010 Sep 2.