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

May 18, 2015 updated by: Mayo Clinic

A Randomized Controlled Trial of Narrowband Ultraviolet B vs Topical Psoralen Plus Ultraviolet A Photochemotherapy for Hand and Foot Dermatoses

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Narrowband Ultraviolet B (TL-01UVB) Therapy
treatments - 3x weekly for 15 months
Procedure: Narrowband Ultraviolet B (TL-01UVB) Therapy
Active Comparator: Topical Psoralen plus ultraviolet A (PUVA)
Treatments - 3x weekly for 15 months
Procedure: Topical Psoralen plus ultraviolet A (PUVA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of treatments required to reach clearance
Time Frame: Baseline to 15 months
Baseline to 15 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in symptom score (erythema, scaling/hyperkeratosis, papular/vesicular eruption, and fissures)
Time Frame: Baseline to 15 months
Baseline to 15 months
Change in global score
Time Frame: Baseline to 15 months
Baseline to 15 months
Number of patients reaching clearance
Time Frame: Baseline to 15 months
Baseline to 15 months
Adverse effects
Time Frame: Baseline to 15 months
Baseline to 15 months
Number of days in remission
Time Frame: Baseline to 15 months
Baseline to 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Mark D. Davis, M.D., Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2435-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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