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

Psoriasis Vulgaris Clinical Trial

Official title:

A Study To Determine the Efficacy of Whole Body Narrowband UVB Phototherapy in People With Darker Skin Types

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00220025
• Other study ID #: JKR-0338
• Status: Completed
• Phase: Phase 1
• First received: September 20, 2005
• Last updated: October 24, 2012
• Start date: June 1999
• Est. completion date: May 2009

Study information

• Verified date: October 2012
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

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.

Locations

Country	Name	City	State
United States	Rockefeller University Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Mary Sullivan-Whalen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and histological improvement of psoriasis		beginning and end of treatment	No