Back to resultsAssessment for Tachyphylaxis to Topical Corticosteroids in the Treatment of Psoriasis (Tachyphylaxis)
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Halobetasol 0.05% ointment
Placebo Ointment
Sponsored by
About this trial
This is an interventional basic science trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Subjects must be at least 18 years of age and in good general health as confirmed by a medical history.
- Females of childbearing potential must have a negative urine pregnancy test on Baseline/Week 0 and must agree to use adequate birth control methods during the entire study (a barrier method i.e. condoms, diaphragm; hormonal contraceptives i.e. birth control pills, implants, or injections; intrauterine device, or abstinence).
- Subjects must be diagnosed with stable plaque psoriasis affecting 1% to 10% body surface area (excluding the face, scalp, groin, axillae or other intertriginous areas).
- Subjects receiving phototherapy for their psoriasis.
- Subjects must have at least two symmetrical lesions suitable for evaluating response to test agents (one on the right side and one on the left side of the body). The severity of the disease for each target lesion at Baseline/Week 0 must be rated at least 2 (Mild) for each of the key psoriasis characteristics (scaling, erythema, and plaque elevation) on the Target Lesion Severity Score.
- Subjects must be able to understand the requirements of the study abide by the restrictions and return for the required examinations.
Exclusion Criteria:
- Female subjects who are pregnant, nursing or planning a pregnancy during the study.
- Subjects with known hypersensitivity to any components of the test medication.
- Subjects with non-plaque psoriasis (e.g. guttate, erythrodermic) or other related diseases not classified as plaque psoriasis.
- Subjects whose psoriasis involves only the scalp, face, groin, axillae, and/or other intertriginous areas.
- Subjects requiring any other medication (topical or systemic) that may affect the course of the disease during the study period as determined by the study investigators.
- Subjects using biologics or any other systemic treatment (e.g. immunosuppressants, acitretin) for psoriasis within 12 weeks of entering the study.
- Subjects using systemic corticosteroids within 28 days of entering the study
- Subjects using topical corticosteroids or other topical therapies (other than emollients) at the treatment area locations within 14 days of entering the study
- Subjects using phototherapy (UVB, PUVA) on target treatment sites within 4 weeks of entering the study.
- Subjects with overt pre-existing telangiectasias or skin atrophy at intended treatment sites (treatment areas).
- Subjects who are using any medication or has any disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active Arm
Vehicle Arm
Arm Description
1. Active arm/Target Lesion: Halobetasol 0.05% ointment applied under occlusion to be left in place for one week
Vehicle arm/Comparator Lesion: Vehicle ointment applied under occlusion to be left in place for one week
Outcomes
Primary Outcome Measures
Time to Tachyphylaxis
Phase 1: %change in TLSS of target lesion versus comparator lesion Phase 2a, after an interim discontinuation period of 4-8 weeks: %change in TLSS of target lesion versus comparator lesion Phase 2b, after an interim discontinuation period of 4-8 weeks: Percent change in TLSS of the comparator lesion (now switched to open-label halobetasol 0.05% ointment) versus target lesion
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01404338
Brief Title
Assessment for Tachyphylaxis to Topical Corticosteroids in the Treatment of Psoriasis
Acronym
Tachyphylaxis
Official Title
An Investigator-Initiated, Double-Blind, Vehicle-Controlled Study: Assessment for Tachyphylaxis to Topical Corticosteroids in the Treatment of Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Patel, Rita Vikram, M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Tachyphylaxis occurs when a medication is applied multiple times and a decreased response takes place. Many dermatologists believe that tachyphylaxis to topical steroids commonly occur. Other believe that tachyphylaxis can be explain by patient non-compliance with topical medications. This study is looking to prove or disprove the phenomenon of tachyphylaxis by using topical steroids in the psoriasis patient population. The investigators are looking to enroll 10 patients with symmetric, bilateral, and small psoriasis plaques. The investigators will either apply a strong topical steroid or a vehicle ointment to the plaques, which is be occluded with a band aid for a one week period. Weekly, the investigators will inspect the plaques for tachyphylaxis. This regimen will be repeated during phase 2, to see if there is change in the time to tachyphylaxis. This regimen will be repeated during phase 3, however, both plaques will be treated with steroid in this phase, and time to tachyphylaxis will be measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Arm
Arm Type
Active Comparator
Arm Description
1. Active arm/Target Lesion: Halobetasol 0.05% ointment applied under occlusion to be left in place for one week
Arm Title
Vehicle Arm
Arm Type
Placebo Comparator
Arm Description
Vehicle arm/Comparator Lesion: Vehicle ointment applied under occlusion to be left in place for one week
Intervention Type
Drug
Intervention Name(s)
Halobetasol 0.05% ointment
Intervention Type
Drug
Intervention Name(s)
Placebo Ointment
Primary Outcome Measure Information:
Title
Time to Tachyphylaxis
Description
Phase 1: %change in TLSS of target lesion versus comparator lesion Phase 2a, after an interim discontinuation period of 4-8 weeks: %change in TLSS of target lesion versus comparator lesion Phase 2b, after an interim discontinuation period of 4-8 weeks: Percent change in TLSS of the comparator lesion (now switched to open-label halobetasol 0.05% ointment) versus target lesion
Time Frame
4 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must be at least 18 years of age and in good general health as confirmed by a medical history.
Females of childbearing potential must have a negative urine pregnancy test on Baseline/Week 0 and must agree to use adequate birth control methods during the entire study (a barrier method i.e. condoms, diaphragm; hormonal contraceptives i.e. birth control pills, implants, or injections; intrauterine device, or abstinence).
Subjects must be diagnosed with stable plaque psoriasis affecting 1% to 10% body surface area (excluding the face, scalp, groin, axillae or other intertriginous areas).
Subjects receiving phototherapy for their psoriasis.
Subjects must have at least two symmetrical lesions suitable for evaluating response to test agents (one on the right side and one on the left side of the body). The severity of the disease for each target lesion at Baseline/Week 0 must be rated at least 2 (Mild) for each of the key psoriasis characteristics (scaling, erythema, and plaque elevation) on the Target Lesion Severity Score.
Subjects must be able to understand the requirements of the study abide by the restrictions and return for the required examinations.
Exclusion Criteria:
Female subjects who are pregnant, nursing or planning a pregnancy during the study.
Subjects with known hypersensitivity to any components of the test medication.
Subjects with non-plaque psoriasis (e.g. guttate, erythrodermic) or other related diseases not classified as plaque psoriasis.
Subjects whose psoriasis involves only the scalp, face, groin, axillae, and/or other intertriginous areas.
Subjects requiring any other medication (topical or systemic) that may affect the course of the disease during the study period as determined by the study investigators.
Subjects using biologics or any other systemic treatment (e.g. immunosuppressants, acitretin) for psoriasis within 12 weeks of entering the study.
Subjects using systemic corticosteroids within 28 days of entering the study
Subjects using topical corticosteroids or other topical therapies (other than emollients) at the treatment area locations within 14 days of entering the study
Subjects using phototherapy (UVB, PUVA) on target treatment sites within 4 weeks of entering the study.
Subjects with overt pre-existing telangiectasias or skin atrophy at intended treatment sites (treatment areas).
Subjects who are using any medication or has any disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study.
12. IPD Sharing Statement
Learn more about this trial
Assessment for Tachyphylaxis to Topical Corticosteroids in the Treatment of Psoriasis
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