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Study of a New Dressing for Use With Topical Medications

Primary Purpose

Psoriasis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Occlusive dressing
Sponsored by
Teikoku Pharma USA, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, hydrogel, occlusive dressing, occlusion, hydrocortisone, tacrolimus, Protopic, triamcinolone, calcipotriene, Dovonex, halobetasol, Ultravate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 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. Exclusion Criteria: 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 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.

Sites / Locations

  • UCSF Psoriasis and Skin Treatment Center

Outcomes

Primary Outcome Measures

Efficacy of topical medications with new occlusive dressing at baseline, weeks 2, 4, 6, 8.

Secondary Outcome Measures

Efficacy with new occlusive dressing alone without topical medications at baseline, weeks 2, 4, 6, 8.

Full Information

First Posted
October 5, 2005
Last Updated
June 30, 2008
Sponsor
Teikoku Pharma USA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00234728
Brief Title
Study of a New Dressing for Use With Topical Medications
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Teikoku Pharma USA, Inc.

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
psoriasis, hydrogel, occlusive dressing, occlusion, hydrocortisone, tacrolimus, Protopic, triamcinolone, calcipotriene, Dovonex, halobetasol, Ultravate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Occlusive dressing
Primary Outcome Measure Information:
Title
Efficacy of topical medications with new occlusive dressing at baseline, weeks 2, 4, 6, 8.
Secondary Outcome Measure Information:
Title
Efficacy with new occlusive dressing alone without topical medications at baseline, weeks 2, 4, 6, 8.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Koo, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Psoriasis and Skin Treatment Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States

12. IPD Sharing Statement

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Study of a New Dressing for Use With Topical Medications

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