Bexarotene With Narrow-Band UVB for Psoriasis

August 6, 2008 updated by: University of Medicine and Dentistry of New Jersey

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

To determine if bexarotene gel with NBUVB phototherapy is more effective than placebo plus NBUVB for moderate to severe plaque-type psoriasis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

35

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Dentistry of New Jersey

Collaborators

Ligand Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

August 7, 2008

Last Update Submitted That Met QC Criteria

August 6, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4405

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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