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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00220025
First Posted: September 22, 2005
Last Update Posted: October 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mary Sullivan-Whalen, Rockefeller University
  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 Phase
Psoriasis Vulgaris Device: Phototherapy Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:


Further study details as provided by Mary Sullivan-Whalen, Rockefeller University:

Primary Outcome Measures:
  • Clinical and histological improvement of psoriasis [ Time Frame: beginning and end of treatment ]

Enrollment: 70
Study Start Date: June 1999
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NBUVB 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

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220025


Locations
United States, New York
Rockefeller University Hospital
New York, New York, United States, 10021
Sponsors and Collaborators
Mary Sullivan-Whalen
Investigators
Principal Investigator: James G. Krueger, MD Rockefeller University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mary Sullivan-Whalen, Co-Investigator, Rockefeller University
ClinicalTrials.gov Identifier: NCT00220025     History of Changes
Other Study ID Numbers: JKR-0338
First Submitted: September 20, 2005
First Posted: September 22, 2005
Last Update Posted: October 25, 2012
Last Verified: October 2012

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