PsoriasisNCT00234728
Study of a New Dressing for Use With Topical Medications
A study testing Occlusive dressing in people with Psoriasis, run by Teikoku Pharma USA, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine if a new dressing designed to be used with topical medications will enhance the effects of these topical medications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Occlusive dressing
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jun 2007
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has signed the informed consent form and HIPAA authorization form
- Male or female subject at least 18 years of age
- A diagnosis of stable plaque-type psoriasis vulgaris with at least one "mirror image" pair of symmetric lesions on either the trunk, arms, or legs that would serve as target lesions. Paired target lesions must be in similar anatomic locations (e.g., right and left elbows or right and left knees) and have roughly equal (no more than one point difference) modified PASI scores. Both paired target lesions must have PASI scores equal to or greater than 1.5
- Any additional diagnoses must, in the investigator's opinion, not preclude the subject from safely participating in this study or interfere with the evaluation of the subject's psoriasis
- Psoriasis must be clinically stable for at least 30 days before enrollment
- Subject is able to completely discontinue the use of any medication or therapy for relief of psoriasis in the target areas to be treated
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- Subject is able to completely discontinue the use of any systemic medication or therapy (e.g. oral or injectable psoriasis medications, PUVA phototherapy, herbal remedies, or acupuncture) for relief of psoriasis
- Female subjects must be postmenopausal (defined as one year without menses), physically incapable of becoming pregnant, or using an acceptable birth control method. Acceptable methods of birth control include hormonal contraceptives or double-barrier methods (condom, diaphragm with spermicidal agent or IUD). If practicing an acceptable method of birth control, the subject must have confirmation of a negative urine pregnancy test at Screening
- Subject must be reliable and mentally competent to complete study measurements
- Subject is able to understand and agrees to comply with study requirements, attend study visits, and comply with the restrictions during the study.
Who cannot join
- Subject has a skin disorder other than psoriasis in the target areas to be evaluated
- Known hypersensitivity to any component of the test medications
- Pigmentation, extensive scarring, or pigmented lesions in affected areas that would interfere with evaluation of efficacy parameters
- Clinically infected psoriasis at baseline
- Subject is pregnant or nursing
- Guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis
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- Spontaneously worsening or improving psoriasis within 30 days of enrollment
- Any evidence of atrophy in the areas selected for treatment with topical corticosteroid
- History of treating potential target lesions differently from one another
- Topical or intralesional therapies (other than emollients) or UVB phototherapy on potential target lesions within two weeks of starting study treatment
- Systemic therapy, PUVA phototherapy, or a systemic investigational therapy for psoriasis within 30 days prior to study entry
- Treatment with topical investigational therapy of the target lesions within 30 days prior to study entry
- Subject is considered unreliable as to medication compliance or adherence to scheduled appointments as determined by the investigators.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Psoriasis and Skin Treatment Center
San Francisco, California, 94118
About this study
Official title: An Open-Label, Bilaterally-Controlled Single Center Study to Compare the Efficacy of Occlusion of Topical Agents With a Hydrophilic Occlusive Dressing to Treatment With Occlusive Dressing Without the Addition of Topical Agents
The purpose of this study is to determine if a new dressing designed to be used with topical medications will enhance the effects of these topical medications.
- Conditions
- Psoriasis
- Being tested
- Occlusive dressing
- Keywords
- psoriasis, hydrogel, occlusive dressing, occlusion, hydrocortisone, tacrolimus, Protopic, triamcinolone, calcipotriene, Dovonex, halobetasol, Ultravate
- Medical subject headings
- Psoriasis, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusive dressingDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of topical medications with new occlusive dressing at baseline, weeks 2, 4, 6, 8.
Secondary outcomes (1)
Efficacy with new occlusive dressing alone without topical medications at baseline, weeks 2, 4, 6, 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2005 (estimated)
- Study startSep 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teikoku Pharma USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John Koo, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234728
- Sponsor's protocol ID
- TPU-2005-02
- Status last verified
- Jun 2008
- First submitted
- 5 Oct 2005
- Last updated
- 2 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Bilaterally-Controlled Single Center Study to Compare the Efficacy of Occlusion of Topical Agents With a Hydrophilic Occlusive Dressing to Treatment With Occlusive Dressing Without the Addition of Topical Agents
- ClinicalTrials.gov ID
- NCT00234728
- Acronym / sponsor ID
- TPU-2005-02
- Conditions
- Psoriasis
- Keywords
- psoriasis, hydrogel, occlusive dressing, occlusion, hydrocortisone, tacrolimus, Protopic, triamcinolone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Teikoku Pharma USA, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- Jun 2007 (actual)
- First posted
- 7 Oct 2005 (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 purpose of this study is to determine if a new dressing designed to be used with topical medications will enhance the effects of these topical medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject has signed the informed consent form and HIPAA authorization form
- Male or female subject at least 18 years of age
- A diagnosis of stable plaque-type psoriasis vulgaris with at least one "mirror image" pair of symmetric lesions on either the trunk, arms, or legs that would serve as target lesions. Paired target lesions must be in similar anatomic locations (e.g., right and left elbows or right and left knees) and have roughly equal (no more than one point difference) modified PASI scores. Both paired target lesions must have PASI scores equal to or greater than 1.5
- Any additional diagnoses must, in the investigator's opinion, not preclude the subject from safely participating in this study or interfere with the evaluation of the subject's psoriasis
- Psoriasis must be clinically stable for at least 30 days before enrollment
Key exclusion criteria (13 listed)
- Subject has a skin disorder other than psoriasis in the target areas to be evaluated
- Known hypersensitivity to any component of the test medications
- Pigmentation, extensive scarring, or pigmented lesions in affected areas that would interfere with evaluation of efficacy parameters
- Clinically infected psoriasis at baseline
- Subject is pregnant or nursing
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 |
|---|---|---|
| Occlusive dressing | Device | – |
Primary outcome
Efficacy of topical medications with new occlusive dressing at baseline, weeks 2, 4, 6, 8.
1 secondary outcome
Efficacy with new occlusive dressing alone without topical medications at baseline, weeks 2, 4, 6, 8.
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 2 Jul 2008.
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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.
John Koo, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occlusive dressing in people with Psoriasis, run by Teikoku Pharma USA, Inc. at 1 site in United States.
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 10 inclusion and 13 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 2 Jul 2008. 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 United States. 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.
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?
Efficacy of topical medications with new occlusive dressing at baseline, weeks 2, 4, 6, 8.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2008.