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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00217009
Recruitment Status : Terminated (Unfortunately we had unforeseen difficulty recruiting to this study. Therefore we have decided to halt the study and not publish the results.)
First Posted : September 22, 2005
Last Update Posted : May 20, 2015
Information provided by:
Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Dermatitis Psoriasis Procedure: Narrowband Ultraviolet B (TL-01UVB) Therapy Procedure: Topical Psoralen plus ultraviolet A (PUVA) Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Narrowband Ultraviolet B vs Topical Psoralen Plus Ultraviolet A Photochemotherapy for Hand and Foot Dermatoses
Study Start Date : March 2005
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

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)

Primary Outcome Measures :
  1. Number of treatments required to reach clearance [ Time Frame: Baseline to 15 months ]

Secondary Outcome Measures :
  1. Change in symptom score (erythema, scaling/hyperkeratosis, papular/vesicular eruption, and fissures) [ Time Frame: Baseline to 15 months ]
  2. Change in global score [ Time Frame: Baseline to 15 months ]
  3. Number of patients reaching clearance [ Time Frame: Baseline to 15 months ]
  4. Adverse effects [ Time Frame: Baseline to 15 months ]
  5. Number of days in remission [ Time Frame: Baseline to 15 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00217009

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Mark D. Davis, M.D. Mayo Clinic

Responsible Party: Mark D Davis, M.D, Mayo Clinic Identifier: NCT00217009     History of Changes
Other Study ID Numbers: 2435-04
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Dermatologic Agents
Photosensitizing Agents
Antiparasitic Agents
Anti-Infective Agents