Study Stopped
Unfortunately we had unforeseen difficulty recruiting to this study. Therefore we have decided to halt the study and not publish the results.
Study to Compare Different Light Therapies (Narrowband Ultraviolet B vs PUVA) for Hand and Foot Skin Diseases.
A Randomized Controlled Trial of Narrowband Ultraviolet B vs Topical Psoralen Plus Ultraviolet A Photochemotherapy for Hand and Foot Dermatoses
1 other identifier
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Mar 2005
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedMay 20, 2015
May 1, 2015
3.7 years
September 14, 2005
May 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of treatments required to reach clearance
Baseline to 15 months
Secondary Outcomes (5)
Change in symptom score (erythema, scaling/hyperkeratosis, papular/vesicular eruption, and fissures)
Baseline to 15 months
Change in global score
Baseline to 15 months
Number of patients reaching clearance
Baseline to 15 months
Adverse effects
Baseline to 15 months
Number of days in remission
Baseline to 15 months
Study Arms (2)
Narrowband Ultraviolet B (TL-01UVB) Therapy
ACTIVE COMPARATORtreatments - 3x weekly for 15 months
Topical Psoralen plus ultraviolet A (PUVA)
ACTIVE COMPARATORTreatments - 3x weekly for 15 months
Interventions
Eligibility Criteria
You may qualify if:
- Bilateral hand or foot skin disease (dermatitis, psoriasis, etc.) with symmetric distribution and severity.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark D. Davis, M.D.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 22, 2005
Study Start
March 1, 2005
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
May 20, 2015
Record last verified: 2015-05