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

This study has been terminated.
(Unfortunately we had unforeseen difficulty recruiting to this study. Therefore we have decided to halt the study and not publish the results.)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00217009
First received: September 14, 2005
Last updated: May 18, 2015
Last verified: May 2015
  Purpose
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 Intervention Phase
Dermatitis
Psoriasis
Procedure: Narrowband Ultraviolet B (TL-01UVB) Therapy
Procedure: Topical Psoralen plus ultraviolet A (PUVA)
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Number of treatments required to reach clearance [ Time Frame: Baseline to 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in symptom score (erythema, scaling/hyperkeratosis, papular/vesicular eruption, and fissures) [ Time Frame: Baseline to 15 months ] [ Designated as safety issue: No ]
  • Change in global score [ Time Frame: Baseline to 15 months ] [ Designated as safety issue: No ]
  • Number of patients reaching clearance [ Time Frame: Baseline to 15 months ] [ Designated as safety issue: No ]
  • Adverse effects [ Time Frame: Baseline to 15 months ] [ Designated as safety issue: Yes ]
  • Number of days in remission [ Time Frame: Baseline to 15 months ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: March 2005
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217009

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

Responsible Party: Mark D Davis, M.D, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00217009     History of Changes
Other Study ID Numbers: 2435-04 
Study First Received: September 14, 2005
Last Updated: May 18, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Psoriasis
Dermatitis
Skin Diseases, Papulosquamous
Skin Diseases
Amotosalen
Furocoumarins
Ficusin
Dermatologic Agents
Photosensitizing Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 26, 2016