STA-21 Topical Efficacy on Psoriasis
This study has been completed.
Sponsor:
Kochi University
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: Topical application of STA-21 ointment for treatment of psoriasis |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Intrapatient Comparison Study of Efficacy of STA-21 Ointment on Psoriatic Skin Lesions |
Resource links provided by NLM:
Further study details as provided by Kochi University:
Primary Outcome Measures:
- 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 ]
| Enrollment: | 8 |
| Study Start Date: | June 2007 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Psoriasis therapy | Drug: Topical application of STA-21 ointment for treatment of psoriasis |
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.
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047943
Locations
| Japan | |
| Department of Dermatology, Kochi Medical School, Kochi University | |
| Nankoku, Japan, 783-8505 | |
Sponsors and Collaborators
Kochi University
Investigators
| Principal Investigator: | Shigetoshi Sano, M.D., Ph.D. | Department of Dermatology, Kochi Medical School, Kochi University |
More Information
No publications provided by Kochi University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Department of Dermatology, Kochi Medical School, Kochi University |
| ClinicalTrials.gov Identifier: | NCT01047943 History of Changes |
| Other Study ID Numbers: | KochiDermaTrial |
| Study First Received: | January 12, 2010 |
| Last Updated: | January 12, 2010 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on June 18, 2013