STA-21 Topical Efficacy on Psoriasis

Psoriasis Clinical Trial

Official title:

Intrapatient Comparison Study of Efficacy of STA-21 Ointment on Psoriatic Skin Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047943
• Other study ID #: KochiDermaTrial
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 12, 2010
• Last updated: January 12, 2010
• Start date: June 2007
• Est. completion date: April 2008

Study information

• Verified date: June 2007
• Source: Kochi University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Topical application of STA-21 ointment for treatment of psoriasis

Locations

Country	Name	City	State
Japan	Department of Dermatology, Kochi Medical School, Kochi University	Nankoku

Sponsors (1)

Lead Sponsor	Collaborator
Kochi University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erythema, induration and scaling are scored on a scale of 0 to4 (O indicating none, 4 very severe)		2 weeks	Yes