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

NCT ID: NCT00220025

Last Updated: 2012-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-06-30

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NBUVB

Group Type EXPERIMENTAL

Phototherapy

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

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Exclusion Criteria

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Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mary Sullivan-Whalen

OTHER

Sponsor Role lead

Responsible Party

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Mary Sullivan-Whalen

Co-Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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James G. Krueger, MD

Role: PRINCIPAL_INVESTIGATOR

Rockefeller University

Locations

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Rockefeller University Hospital

New York, New York, United States

Site Status

Countries

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United States

References

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Johnson-Huang LM, Suarez-Farinas 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.

Reference Type DERIVED
PMID: 20555351 (View on PubMed)

Other Identifiers

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JKR-0338

Identifier Type: -

Identifier Source: org_study_id