Assessment for Tachyphylaxis to Topical Corticosteroids in the Treatment of Psoriasis (Tachyphylaxis)

• ClinicalTrials.gov Identifier: NCT01404338
• Recruitment Status: Completed
• First Posted: July 28, 2011
• Last Update Posted: July 28, 2011
• Sponsor: Patel, Rita Vikram, M.D.
• Information provided by: Patel, Rita Vikram, M.D.

Tracking Information

• First Submitted Date: July 25, 2011
• First Posted Date: July 28, 2011
• Last Update Posted Date: July 28, 2011
• Study Start Date: June 2011
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: July 27, 2011)

Time to Tachyphylaxis [ Time Frame: 4 Weeks ]

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessment for Tachyphylaxis to Topical Corticosteroids in the Treatment of Psoriasis
• Official Title: An Investigator-Initiated, Double-Blind, Vehicle-Controlled Study: Assessment for Tachyphylaxis to Topical Corticosteroids in the Treatment of Psoriasis
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double; Primary Purpose: Basic Science
• Condition: Psoriasis

Intervention

• Drug: Halobetasol 0.05% ointment
• Drug: Placebo Ointment

Study Arms

• Active Comparator: Active Arm
  1. Active arm/Target Lesion: Halobetasol 0.05% ointment applied under occlusion to be left in place for one week
  Intervention: Drug: Halobetasol 0.05% ointment
• Placebo Comparator: Vehicle Arm
  Vehicle arm/Comparator Lesion: Vehicle ointment applied under occlusion to be left in place for one week
  Intervention: Drug: Placebo Ointment

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 27, 2011): 10
• Original Actual Enrollment: Same as current
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01404338
• Other Study ID Numbers: 11-0422
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Patel, Rita Vikram, M.D.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Patel, Rita Vikram, M.D.
• Verification Date: July 2011