STA-21 Topical Efficacy on Psoriasis

This study has been completed.
Sponsor:
Information provided by:
Kochi University
ClinicalTrials.gov Identifier:
NCT01047943
First received: January 12, 2010
Last updated: NA
Last verified: June 2007
History: No changes posted

January 12, 2010
January 12, 2010
June 2007
April 2008   (final data collection date for primary outcome measure)
Erythema, induration and scaling are scored on a scale of 0 to4 (O indicating none, 4 very severe) [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
STA-21 Topical Efficacy on Psoriasis
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis
Drug: Topical application of STA-21 ointment for treatment of psoriasis
Experimental: Psoriasis therapy
Intervention: Drug: Topical application of STA-21 ointment for treatment of psoriasis
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. Epub 2010 Sep 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
April 2008
April 2008   (final data collection date for primary outcome measure)

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.
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01047943
KochiDermaTrial
No
Department of Dermatology, Kochi Medical School, Kochi University
Kochi University
Not Provided
Principal Investigator: Shigetoshi Sano, M.D., Ph.D. Department of Dermatology, Kochi Medical School, Kochi University
Kochi University
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP