Narrowband UVB Light Therapy to Patients With Dark Skin Types Who Have 10% of Their Body Involved With Psoriasis Vulgaris. - Full Text View

Sponsored by:	Rockefeller University
Information provided by:	Rockefeller University
ClinicalTrials.gov Identifier:	NCT00220025

Purpose

This study offers narrowband UVB light therapy to patients with both light and dark skin types who have 10% of their body involved with psoriasis vulgaris.

Condition	Intervention
Psoriasis Vulgaris	Device: Phototherapy

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study To Determine the Efficacy of Whole Body Narrowband UVB Phototherapy in People With Darker Skin Types

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Rockefeller University:

Primary Outcome Measures:

Clinical and histological improvement of psoriasis [ Time Frame: beginning and end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	June 1999
Estimated Study Completion Date:	December 2009

Arms	Assigned Interventions
NBUVB: Experimental	Device: Phototherapy The patient begins total body NBUVB that day at a dose that is 50% of the MED. Patients are treated 3-7 times per week, with increasing doses at every treatment if no burning occurs. This is continued until clearance of disease or maximum efficacy.

Detailed Description:

Two groups of patients, having 10% of their body surface area involved with psoriasis vulgaris, will receive narrowband phototherapy. One group will have skin type I-IV, or light skin and the second group will have dark skin, or type V-VI. All patients will receive phototherapy, with narrowband UVB, three times a week for six weeks, or a total of 18 treatments. 6mm punch skin biopsies will be done prior to starting therapy and at the completion of the study.

Clinical assessments and photography will be done parallel to the skin biopsies. Results (clinically and histologically) of both groups will be compared.

Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have stable psoriasis vulgaris, which covers at least 10% of their bodies, for at least six months. Patients can not have not been treated with narrowband UVB in the past, although other light therapies are acceptable (i.e. broadband UVB and PUVA). Patients are not allowed to receive other therapies for their psoriasis, internal and topical, while they are participating in the study. Patients may continue using non-medicated moisturizer. -

Exclusion Criteria:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220025

Locations

United States, New York
Rockefeller University Hospital
New York, New York, United States, 10021

Sponsors and Collaborators

Rockefeller University

Investigators

Principal Investigator:

James G. Krueger, MD

Rockefeller University

More Information

Additional Information:

The Rockefeller University Hospital This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Rockefeller University ( James Kreuger, MD )
Study ID Numbers:	RUH IRB # JKR 338
Study First Received:	September 20, 2005
Last Updated:	July 20, 2009
ClinicalTrials.gov Identifier:	NCT00220025 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Study placed in the following topic categories:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on September 11, 2009