search
Back to results

Bexarotene With Narrow-Band UVB for Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bexarotene/NBUVB vs placebo NBUVB
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring psoriasis, bexarotene, narrow band, UVB

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Patient must be a male or female aged 18 years or older Patient must have moderate to severe psoriasis vulgaris of at least 3% body surface area involvement Patient must have failed prior topical therapy Patient must be willing to minimize sun exposure, to use sun blockers if deemed necessary by the Investigator and to avoid use of tanning booths or other ultraviolet (UV) light sources Women of childbearing potential must have a negative urine ß-HCG pregnancy test with a sensitivity of at least 50 mIU/mL within seven days prior to starting of study gels and repeated every four weeks while patient remains on the study gels. All females of childbearing potential must agree to use 2 effective contraceptive methods or remain sexually abstinent one month prior to initiation of study drug, during the entire study period, and for one month after the last application of Targretin® gel 1%. Acceptable methods of birth control include: condoms with spermicide; diaphragm with spermicide; cervical cap with spermicide; spermicidal sponge; intrauterine device (IUD), oral contraceptives, Depo-Provera; contraceptive implants; vasectomy; or abstinence. Male patients must agree to use condoms with sexual partners of childbearing potential during the entire period of treatment and for at least one month after treatment is discontinued. Patients who are not sexually active and are not using contraception, must agree to use an approved method of contraception (as described above) should they become sexually active during the study Exclusion Criteria Failure to understand the consent form Inability to comply with protocol requirements Pregnancy Inadequate birth control method Lactation Contraindication to use of topical retinoids Concomitant psoriasis therapies except for emollients and OTC shampoos Systemic psoriasis therapies, systemic Vitamin A in doses > 15,000IU/day, PUVA, (psoralen plus ultraviolet A irradiation), UVB, topical psoriasis therapies (other than emollients and OTC shampoos), other retinoid class drugs or investigational drugs within the past 1 month Current skin cancer History of previous melanoma History of skin sensitizing diseases (such as SLE) Concurrent medical illness that would make participation in this clinical trial ill-advised Patient unwilling or unable to avoid prolonged exposure to the sun or other UV light sources

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Mean decrease in target lesion size for drug- and placebo-treated sides. The mean and median changes in target lesion scores will be compared for drug- and vehicle-treated sides. Additionally, target lesions will be photographed.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 6, 2005
    Last Updated
    August 6, 2008
    Sponsor
    University of Medicine and Dentistry of New Jersey
    Collaborators
    Ligand Pharmaceuticals
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00151008
    Brief Title
    Bexarotene With Narrow-Band UVB for Psoriasis
    Official Title
    Investigator-Initiated, Double Blind, Vehicle-Controlled, Bilateral Comparison Trial of Bexarotene (Targretin) Gel 1% vs. Vehicle Gel in Combination With Narrow Band UVB Phototherapy for Moderate to Severe Psoriasis Vulgaris
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Medicine and Dentistry of New Jersey
    Collaborators
    Ligand Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To determine if bexarotene gel with NBUVB phototherapy is more effective than placebo plus NBUVB for moderate to severe plaque-type psoriasis.
    Detailed Description
    Subjects will be applying active gel or placebo to target lesions to each side of the body in a blinded manner. They will start at three times a week and increase to daily or even twice a day regimen if tolerated. After 2 weeks of application, NBUVB will be added to treatment regimen (whole body, three times a week). Total study time is 10 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis
    Keywords
    psoriasis, bexarotene, narrow band, UVB

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    35 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Bexarotene/NBUVB vs placebo NBUVB
    Primary Outcome Measure Information:
    Title
    Mean decrease in target lesion size for drug- and placebo-treated sides. The mean and median changes in target lesion scores will be compared for drug- and vehicle-treated sides. Additionally, target lesions will be photographed.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria Patient must be a male or female aged 18 years or older Patient must have moderate to severe psoriasis vulgaris of at least 3% body surface area involvement Patient must have failed prior topical therapy Patient must be willing to minimize sun exposure, to use sun blockers if deemed necessary by the Investigator and to avoid use of tanning booths or other ultraviolet (UV) light sources Women of childbearing potential must have a negative urine ß-HCG pregnancy test with a sensitivity of at least 50 mIU/mL within seven days prior to starting of study gels and repeated every four weeks while patient remains on the study gels. All females of childbearing potential must agree to use 2 effective contraceptive methods or remain sexually abstinent one month prior to initiation of study drug, during the entire study period, and for one month after the last application of Targretin® gel 1%. Acceptable methods of birth control include: condoms with spermicide; diaphragm with spermicide; cervical cap with spermicide; spermicidal sponge; intrauterine device (IUD), oral contraceptives, Depo-Provera; contraceptive implants; vasectomy; or abstinence. Male patients must agree to use condoms with sexual partners of childbearing potential during the entire period of treatment and for at least one month after treatment is discontinued. Patients who are not sexually active and are not using contraception, must agree to use an approved method of contraception (as described above) should they become sexually active during the study Exclusion Criteria Failure to understand the consent form Inability to comply with protocol requirements Pregnancy Inadequate birth control method Lactation Contraindication to use of topical retinoids Concomitant psoriasis therapies except for emollients and OTC shampoos Systemic psoriasis therapies, systemic Vitamin A in doses > 15,000IU/day, PUVA, (psoralen plus ultraviolet A irradiation), UVB, topical psoriasis therapies (other than emollients and OTC shampoos), other retinoid class drugs or investigational drugs within the past 1 month Current skin cancer History of previous melanoma History of skin sensitizing diseases (such as SLE) Concurrent medical illness that would make participation in this clinical trial ill-advised Patient unwilling or unable to avoid prolonged exposure to the sun or other UV light sources
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Melissa Magliocco, MD
    Organizational Affiliation
    Rutgers, The State University of New Jersey
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Bexarotene With Narrow-Band UVB for Psoriasis

    We'll reach out to this number within 24 hrs