STA-21 Topical Efficacy on Psoriasis

NCT ID: NCT01047943

Last Updated: 2010-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-04-30

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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Psoriasis therapy

Group Type: EXPERIMENTAL

Topical application of STA-21 ointment for treatment of psoriasis

Intervention Type: DRUG

Interventions

Topical application of STA-21 ointment for treatment of psoriasis

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kochi University

OTHER

Sponsor Role: lead

Responsible Party

Kochi Medical School, Kochi University

Principal Investigators

Shigetoshi Sano, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Kochi Medical School, Kochi University

Locations

Department of Dermatology, Kochi Medical School, Kochi University

Nankoku, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 20811392 (View on PubMed)

Other Identifiers

KochiDermaTrial

Identifier Type: -

Identifier Source: org_study_id