Bexarotene With Narrow-Band UVB for Psoriasis - Full Text View

Sponsors and Collaborators:	University of Medicine and Dentistry New Jersey Ligand Pharmaceuticals
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00151008

Purpose

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

Condition	Intervention	Phase
Psoriasis	Drug: Bexarotene/NBUVB vs placebo NBUVB	Phase II

MedlinePlus related topics: Psoriasis

Drug Information available for: Bexarotene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
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

Further study details as provided by University of Medicine and Dentistry New Jersey:

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.

Estimated Enrollment:	35
Study Start Date:	November 2003
Estimated Study Completion Date:	August 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151008

Sponsors and Collaborators

University of Medicine and Dentistry New Jersey

Ligand Pharmaceuticals

Investigators

Principal Investigator:

Melissa Magliocco, MD

University of Medicine and Dentistry New Jersey

More Information

Study ID Numbers:	4405
Study First Received:	September 6, 2005
Last Updated:	August 6, 2008
ClinicalTrials.gov Identifier:	NCT00151008
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:

psoriasis
bexarotene
narrow band
UVB

Study placed in the following topic categories:

Skin Diseases
Bexarotene
Psoriasis
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009