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

Primary Purpose

Dermatitis, Psoriasis

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Narrowband Ultraviolet B (TL-01UVB) Therapy
Topical Psoralen plus ultraviolet A (PUVA)
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Narrowband Ultraviolet B (TL-01UVB) Therapy

Topical Psoralen plus ultraviolet A (PUVA)

Arm Description

treatments - 3x weekly for 15 months

Treatments - 3x weekly for 15 months

Outcomes

Primary Outcome Measures

Number of treatments required to reach clearance

Secondary Outcome Measures

Change in symptom score (erythema, scaling/hyperkeratosis, papular/vesicular eruption, and fissures)
Change in global score
Number of patients reaching clearance
Adverse effects
Number of days in remission

Full Information

First Posted
September 14, 2005
Last Updated
May 18, 2015
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00217009
Brief Title
Study to Compare Different Light Therapies (Narrowband Ultraviolet B vs PUVA) for Hand and Foot Skin Diseases.
Official Title
A Randomized Controlled Trial of Narrowband Ultraviolet B vs Topical Psoralen Plus Ultraviolet A Photochemotherapy for Hand and Foot Dermatoses
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
Unfortunately we had unforeseen difficulty recruiting to this study. Therefore we have decided to halt the study and not publish the results.
Study Start Date
March 2005 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Narrowband Ultraviolet B (TL-01UVB) Therapy
Arm Type
Active Comparator
Arm Description
treatments - 3x weekly for 15 months
Arm Title
Topical Psoralen plus ultraviolet A (PUVA)
Arm Type
Active Comparator
Arm Description
Treatments - 3x weekly for 15 months
Intervention Type
Procedure
Intervention Name(s)
Narrowband Ultraviolet B (TL-01UVB) Therapy
Intervention Type
Procedure
Intervention Name(s)
Topical Psoralen plus ultraviolet A (PUVA)
Primary Outcome Measure Information:
Title
Number of treatments required to reach clearance
Time Frame
Baseline to 15 months
Secondary Outcome Measure Information:
Title
Change in symptom score (erythema, scaling/hyperkeratosis, papular/vesicular eruption, and fissures)
Time Frame
Baseline to 15 months
Title
Change in global score
Time Frame
Baseline to 15 months
Title
Number of patients reaching clearance
Time Frame
Baseline to 15 months
Title
Adverse effects
Time Frame
Baseline to 15 months
Title
Number of days in remission
Time Frame
Baseline to 15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark D. Davis, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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