UVA 1 Phototherapy for Vitiligo
1 other identifier
interventional
16
1 country
1
Brief Summary
Vitiligo is a chronic acquired disease characterized by well defined white macules and patches affecting the skin. There are many treatment modalities available for vitiligo, however, none of them cure the disease. Ultraviolet A1 (UVA1) phototherapy has been shown to be useful for a variety of skin diseases. However, there are only a few studies published on the efficacy of UVA1 in vitiligo. This is a prospective single-blind randomized clinical trial to assess efficacy and safety of UVA1 in the treatment of vitiligo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 4, 2013
CompletedFirst Posted
Study publicly available on registry
February 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedJuly 2, 2015
June 1, 2015
2.8 years
February 4, 2013
June 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the modified VASI score compared to baseline.
assessments at 2, 4, 6, and 8 weeks during treatment then at 4, 8, and 12 weeks post treatment
Secondary Outcomes (1)
Assessment of side effects in each half including erythema, pruritus, and polymorphous light eruption
assessments at 2, 4, 6, and 8 weeks during treatment then at 4, 8, and 12 weeks post treatment
Study Arms (2)
No treatment (covered)
NO INTERVENTIONUVA1
ACTIVE COMPARATORInterventions
Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into two halves. One half will be shielded by foil and served as control while the other half will be exposed to UVA1. The dose of UVA1 will be 60 J/cm2, 5 times a week for 4 weeks. Patients that have no or less than 10% pigmentation change after 4 weeks will receive UVA1 130J/cm2, 5 times a week for another 4 weeks. The patients with more than 10% pigmentation change will receive UVA1 60 J/cm2, 5times a week for another 4weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment.
Eligibility Criteria
You may qualify if:
- Age \> 18 years.
- Localized or generalized vitiligo that involves a non mucosal or acral site.
- Patients should have a patch of at least 25 cm2 that shows no more than 10% repigmentation as assessed visually
You may not qualify if:
- Patients who received treatment for vitiligo within the past 3 weeks.
- Patients known to have a photosensitivity disorder
- History of previous skin cancer.
- History of severe medical illness or immunosuppression.
- Pregnancy or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Skin Care Center, Vancouver General Hospital
Vancouver, British Columbia, V5Z 4E8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harvey Lui, MD, FRCPC
University of British Columbia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2013
First Posted
February 11, 2013
Study Start
February 1, 2013
Primary Completion
December 1, 2015
Last Updated
July 2, 2015
Record last verified: 2015-06