Study of a New Dressing for Use With Topical Medications

This study has been completed.
Sponsor:
Information provided by:
Teikoku Pharma USA
ClinicalTrials.gov Identifier:
NCT00234728
First received: October 5, 2005
Last updated: June 30, 2008
Last verified: June 2008
  Purpose

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.


Condition Intervention
Psoriasis
Device: Occlusive dressing

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Teikoku Pharma USA:

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.

Estimated Enrollment: 120
Study Start Date: September 2005
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234728

Locations
United States, California
UCSF Psoriasis and Skin Treatment Center
San Francisco, California, United States, 94118
Sponsors and Collaborators
Teikoku Pharma USA
Investigators
Principal Investigator: John Koo, MD University of California, San Francisco
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00234728     History of Changes
Other Study ID Numbers: TPU-2005-02
Study First Received: October 5, 2005
Last Updated: June 30, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Teikoku Pharma USA:
psoriasis
hydrogel
occlusive dressing
occlusion
hydrocortisone
tacrolimus
Protopic
triamcinolone
calcipotriene
Dovonex
halobetasol
Ultravate

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on October 20, 2014