STA-21 Topical Efficacy on Psoriasis
Intrapatient Comparison Study of Efficacy of STA-21 Ointment on Psoriatic Skin Lesions
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 12, 2010
CompletedFirst Posted
Study publicly available on registry
January 13, 2010
CompletedJanuary 13, 2010
June 1, 2007
10 months
January 12, 2010
January 12, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Erythema, induration and scaling are scored on a scale of 0 to4 (O indicating none, 4 very severe)
2 weeks
Study Arms (1)
Psoriasis therapy
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kochi Universitylead
Study Sites (1)
Department of Dermatology, Kochi Medical School, Kochi University
Nankoku, 783-8505, Japan
Related Publications (1)
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.
PMID: 20811392DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shigetoshi Sano, M.D., Ph.D.
Department of Dermatology, Kochi Medical School, Kochi University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 12, 2010
First Posted
January 13, 2010
Study Start
June 1, 2007
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
January 13, 2010
Record last verified: 2007-06