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

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ClinicalTrials.gov Identifier: NCT00220025
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : October 25, 2012
Sponsor:
Information provided by (Responsible Party):
Mary Sullivan-Whalen, Rockefeller University

September 20, 2005
September 22, 2005
October 25, 2012
June 1999
May 2009   (Final data collection date for primary outcome measure)
Clinical and histological improvement of psoriasis [ Time Frame: beginning and end of treatment ]
Clinical and histological improvement of psoriasis
Complete list of historical versions of study NCT00220025 on ClinicalTrials.gov Archive Site
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Narrowband UVB Light Therapy to Patients With Dark Skin Types Who Have 10% of Their Body Involved With Psoriasis Vulgaris.
A Study To Determine the Efficacy of Whole Body Narrowband UVB Phototherapy in People With Darker Skin Types
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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Psoriasis Vulgaris
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.
Experimental: NBUVB
Intervention: Device: Phototherapy
Johnson-Huang LM, Suárez-Fariñas M, Sullivan-Whalen M, Gilleaudeau P, Krueger JG, Lowes MA. Effective narrow-band UVB radiation therapy suppresses the IL-23/IL-17 axis in normalized psoriasis plaques. J Invest Dermatol. 2010 Nov;130(11):2654-63. doi: 10.1038/jid.2010.166. Epub 2010 Jun 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
Same as current
May 2009
May 2009   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: All
14 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00220025
JKR-0338
Yes
Not Provided
Not Provided
Mary Sullivan-Whalen, Rockefeller University
Mary Sullivan-Whalen
Not Provided
Principal Investigator: James G. Krueger, MD Rockefeller University
Rockefeller University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP