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Completed

NCT Number: NCT01047943

STA-21 Topical Efficacy on Psoriasis

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Dermatology, Kochi Medical School, Kochi University

Nankoku, 783-8505, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topical application of STA-21 ointment for treatment of psoriasis

Drug

Primary outcomes

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

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Kochi University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 13, 2010
Registry last updated
Jan 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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