STA-21 Topical Efficacy on Psoriasis

• Sponsor: Kochi University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01047943
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Duration (Months): 10
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: Topical application of STA-21 ointment for treatment of psoriasis	Phase 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Intrapatient Comparison Study of Efficacy of STA-21 Ointment on Psoriatic Skin Lesions
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Psoriasis therapy	Drug: Topical application of STA-21 ointment for treatment of psoriasis

Outcome Measures

Primary Outcome Measures

1. Erythema, induration and scaling are scored on a scale of 0 to4 (O indicating none, 4 very severe) [2 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Dermatology, Kochi Medical School, Kochi University	Nankoku		Japan	783-8505

Sponsors and Collaborators

• Kochi University

Investigators

• Principal Investigator: Shigetoshi Sano, M.D., Ph.D., Department of Dermatology, Kochi Medical School, Kochi University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01047943
• Other Study ID Numbers: KochiDermaTrial
• First Posted: Jan 13, 2010
• Last Update Posted: Jan 13, 2010
• Last Verified: Jun 1, 2007

• Additional relevant MeSH terms: Psoriasis

Study Results

No Results Posted as of Jan 13, 2010