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STA-21 Topical Efficacy on Psoriasis

This study has been completed.
Information provided by:
Kochi University Identifier:
First received: January 12, 2010
Last updated: NA
Last verified: June 2007
History: No changes posted
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 Intervention Phase
Psoriasis Drug: Topical application of STA-21 ointment for treatment of psoriasis Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Kochi University:

Primary Outcome Measures:
  • Erythema, induration and scaling are scored on a scale of 0 to4 (O indicating none, 4 very severe) [ Time Frame: 2 weeks ]

Enrollment: 8
Study Start Date: June 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psoriasis therapy Drug: Topical application of STA-21 ointment for treatment of psoriasis

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.

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
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.
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Please refer to this study by its identifier: NCT01047943

Department of Dermatology, Kochi Medical School, Kochi University
Nankoku, Japan, 783-8505
Sponsors and Collaborators
Kochi University
Principal Investigator: Shigetoshi Sano, M.D., Ph.D. Department of Dermatology, Kochi Medical School, Kochi University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Department of Dermatology, Kochi Medical School, Kochi University Identifier: NCT01047943     History of Changes
Other Study ID Numbers: KochiDermaTrial
Study First Received: January 12, 2010
Last Updated: January 12, 2010

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases processed this record on September 21, 2017