Assessment for Tachyphylaxis to Topical Corticosteroids in the Treatment of Psoriasis

This study has been completed.
Sponsor:
Information provided by:
Patel, Rita Vikram, M.D.
ClinicalTrials.gov Identifier:
NCT01404338
First received: July 25, 2011
Last updated: July 27, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: Halobetasol 0.05% ointment
Drug: Placebo Ointment
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Basic Science
Official Title: An Investigator-Initiated, Double-Blind, Vehicle-Controlled Study: Assessment for Tachyphylaxis to Topical Corticosteroids in the Treatment of Psoriasis

Resource links provided by NLM:


Further study details as provided by Patel, Rita Vikram, M.D.:

Primary Outcome Measures:
  • Time to Tachyphylaxis [ Time Frame: 4 Weeks ] [ Designated as safety issue: Yes ]
    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


Enrollment: 10
Study Start Date: June 2011
Arms Assigned Interventions
Active Comparator: Active Arm
1. Active arm/Target Lesion: Halobetasol 0.05% ointment applied under occlusion to be left in place for one week
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
Drug: Placebo Ointment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01404338     History of Changes
Other Study ID Numbers: 11-0422
Study First Received: July 25, 2011
Last Updated: July 27, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Halobetasol
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014