UVA 1 Phototherapy for Vitiligo
Primary Purpose
Vitiligo
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
UVA1
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo focused on measuring Vitiligo, UVA1, Phototherapy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- The Skin Care Center, Vancouver General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
No treatment (covered)
UVA1
Arm Description
Outcomes
Primary Outcome Measures
Change in the modified VASI score compared to baseline.
Secondary Outcome Measures
Assessment of side effects in each half including erythema, pruritus, and polymorphous light eruption
Full Information
NCT ID
NCT01787695
First Posted
February 4, 2013
Last Updated
June 30, 2015
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT01787695
Brief Title
UVA 1 Phototherapy for Vitiligo
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
4. Oversight
5. Study Description
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.
Detailed Description
Vitiligo is a chronic acquired disease characterized by well defined white macules and patches affecting the skin and mucous membranes. Mucocutaneous lesions develop secondary to selective destruction of melanocytes. The etiology of vitiligo is largely unknown but more likely to be multifactorial. There are several theories on the pathogenesis of vitiligo including mainly the autoimmune, neurohormonal, and autocytotoxic theories. The autoimmune hypothesis has the strongest evidence with alteration mainly in the cellular immune response.
There are many treatment modalities available for vitiligo, however, none of them cure the disease. These include different topical treatments, phototherapy, surgical therapy, and depigmentation therapy. Narrow-band UVB (NB-UVB) is currently the preferred treatment over topical psoralen and ultraviolet A radiation (PUVA), for patients with vitiligo. However, overall response of vitiligo to NB-UVB has been variable. Ultraviolet A1(UVA1) phototherapy is now useful for a variety of skin diseases, specifically scleroderma. There are only a few studies published on the efficacy of UVA1 in vitiligo.
One of the main side effects of UVA1 is prominent tanning which might be due to melanocyte stimulation. Therefore, the investigators hypothesis is that UVA1 will induce significant skin pigmentation to improve vitiligo. The investigators plan on conducting a prospective single-blind randomized clinical trial to assess efficacy and safety of UVA1 in the treatment of vitiligo.
Study Objectives
To evaluate the potential for UVA1 to induce repigmentation within vitiligo patches.
To assess the side effect profile of UVA1 when used in the treatment of vitiligo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
Vitiligo, UVA1, Phototherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No treatment (covered)
Arm Type
No Intervention
Arm Title
UVA1
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
UVA1
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the modified VASI score compared to baseline.
Time Frame
assessments at 2, 4, 6, and 8 weeks during treatment then at 4, 8, and 12 weeks post treatment
Secondary Outcome Measure Information:
Title
Assessment of side effects in each half including erythema, pruritus, and polymorphous light eruption
Time Frame
assessments at 2, 4, 6, and 8 weeks during treatment then at 4, 8, and 12 weeks post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Harvey Lui, MD, FRCPC
Phone
17788595522
Email
harvey.lui@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harvey Lui, MD, FRCPC
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Skin Care Center, Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harvey I Lui, MD FRCPC
Phone
16048754111
Ext
68691
Email
harvey.lui@ubc.ca
First Name & Middle Initial & Last Name & Degree
Harvey Lui, MD FRCPC
12. IPD Sharing Statement
Learn more about this trial
UVA 1 Phototherapy for Vitiligo
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