PsoriasisPhase 1/2NCT01047943
STA-21 Topical Efficacy on Psoriasis
A Phase 1/2 study testing Topical application of STA-21 ointment for treatment of psoriasis in people with Psoriasis, run by Kochi University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Topical application of STA-21 ointment for treatment of psoriasis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2007to Apr 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Dermatology, Kochi Medical School, Kochi University
Nankoku, 783-8505
About this study
Official title: 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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- Topical application of STA-21 ointment for treatment of psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical application of STA-21 ointment for treatment of psoriasisDrug
| Study group | Role | What they receive |
|---|---|---|
| Psoriasis therapy | Experimental | Not described Receives: Drug: Topical application of STA-21 ointment for treatment of psoriasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythema, induration and scaling are scored on a scale of 0 to4 (O indicating none, 4 very severe)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startJun 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kochi University
- Sponsor type
- University, hospital or other
- Investigators
- Shigetoshi Sano, M.D., Ph.D., Principal investigator, Department of Dermatology, Kochi Medical School, Kochi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047943
- Sponsor's protocol ID
- KochiDermaTrial
- Status last verified
- Jun 2007
- First submitted
- 12 Jan 2010
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20811392
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapatient Comparison Study of Efficacy of STA-21 Ointment on Psoriatic Skin Lesions
- ClinicalTrials.gov ID
- NCT01047943
- Acronym / sponsor ID
- KochiDermaTrial
- Conditions
- Psoriasis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Kochi UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psoriasis therapy | Experimental | Drug: Topical application of STA-21 ointment for treatment of psoriasis |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical application of STA-21 ointment for treatment of psoriasis | Drug | Psoriasis therapy |
Primary outcome
Erythema, induration and scaling are scored on a scale of 0 to4 (O indicating none, 4 very severe)
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
- Derived from this study: PubMed 20811392Miyoshi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shigetoshi Sano, M.D., Ph.D. principal investigator
Department of Dermatology, Kochi Medical School, Kochi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Topical application of STA-21 ointment for treatment of psoriasis in people with Psoriasis, run by Kochi University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01047943, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2010.