STA-21 Topical Efficacy on Psoriasis

January 12, 2010 updated by: Kochi University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Nankoku, Japan, 783-8505
        • Department of Dermatology, Kochi Medical School, Kochi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kochi University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

April 1, 2008

Study Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

January 12, 2010

First Posted (ESTIMATE)

January 13, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 13, 2010

Last Update Submitted That Met QC Criteria

January 12, 2010

Last Verified

June 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KochiDermaTrial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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