Back to resultsSTA-21 Topical Efficacy on Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Topical application of STA-21 ointment for treatment of psoriasis
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
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.
Sites / Locations
- Department of Dermatology, Kochi Medical School, Kochi University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Psoriasis therapy
Arm Description
Outcomes
Primary Outcome Measures
Erythema, induration and scaling are scored on a scale of 0 to4 (O indicating none, 4 very severe)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01047943
Brief Title
STA-21 Topical Efficacy on Psoriasis
Official Title
Intrapatient Comparison Study of Efficacy of STA-21 Ointment on Psoriatic Skin Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kochi University
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psoriasis therapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Topical application of STA-21 ointment for treatment of psoriasis
Primary Outcome Measure Information:
Title
Erythema, induration and scaling are scored on a scale of 0 to4 (O indicating none, 4 very severe)
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigetoshi Sano, M.D., Ph.D.
Organizational Affiliation
Department of Dermatology, Kochi Medical School, Kochi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, Kochi Medical School, Kochi University
City
Nankoku
ZIP/Postal Code
783-8505
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
20811392
Citation
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. doi: 10.1038/jid.2010.255. Epub 2010 Sep 2.
Results Reference
derived
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STA-21 Topical Efficacy on Psoriasis
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