Study to Compare Different Light Therapies (Narrowband Ultraviolet B vs PUVA) for Hand and Foot Skin Diseases.

NCT ID: NCT00217009

Last Updated: 2015-05-20

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

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-11-30

Brief Summary

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Hand and foot skin diseases, such as dermatitis and psoriasis, that do not respond to topical creams can be treated with ultraviolet light therapy. Topical psoralen plus ultraviolet A (PUVA) is commonly used to treat these conditions, but requires additional time for the hands and feet to soak in psoralens before the light treatment. Newer narrowband ultraviolet B (NBUVB) units have become available which allow for light treatment without soaking first. The purpose of this study is to determine if NBUVB is as effective as PUVA for hand and foot skin diseases.

Detailed Description

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Conditions

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Dermatitis Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Narrowband Ultraviolet B (TL-01UVB) Therapy

treatments - 3x weekly for 15 months

Group Type ACTIVE_COMPARATOR

Narrowband Ultraviolet B (TL-01UVB) Therapy

Intervention Type PROCEDURE

Topical Psoralen plus ultraviolet A (PUVA)

Treatments - 3x weekly for 15 months

Group Type ACTIVE_COMPARATOR

Topical Psoralen plus ultraviolet A (PUVA)

Intervention Type PROCEDURE

Interventions

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Narrowband Ultraviolet B (TL-01UVB) Therapy

Intervention Type PROCEDURE

Topical Psoralen plus ultraviolet A (PUVA)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Bilateral hand or foot skin disease (dermatitis, psoriasis, etc.) with symmetric distribution and severity.

Exclusion Criteria

Age \<18 years Pregnancy Liver disease Kidney disease History of skin cancer Phototherapy or systemic therapy for the skin condition in the preceding 3 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Principal Investigators

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Mark D. Davis, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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2435-04

Identifier Type: -

Identifier Source: org_study_id

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