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Efficacy of Red Light in Vitiligo

Primary Purpose

Vitiligo

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Red light
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo focused on measuring Vitiligo, red, laser, light

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 3

Arm 4

Arm Type

Active Comparator

Active Comparator

No Intervention

No Intervention

Arm Label

Low intensity red laser

High intensity red light

No treatment1 (covered)

No treatment2 (covered)

Arm Description

Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into four quadrants. Two opposite quadrants will be shielded by foil and served as control, the third quadrant will be exposed to low intensity red laser (at 3 J/cm¬2), and the fourth quadrant will be exposed to high intensity red light (at 37 J/cm¬2). Treatments will be given twice weekly for 10 weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment.

Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into four quadrants. Two opposite quadrants will be shielded by foil and served as control, the third quadrant will be exposed to low intensity red laser (at 3 J/cm¬2), and the fourth quadrant will be exposed to high intensity red light (at 37 J/cm¬2). Treatments will be given twice weekly for 10 weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment.

Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into four quadrants. Two opposite quadrants will be shielded by foil and served as control, the third quadrant will be exposed to low intensity red laser (at 3 J/cm¬2), and the fourth quadrant will be exposed to high intensity red light (at 37 J/cm¬2). Treatments will be given twice weekly for 10 weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment.

Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into four quadrants. Two opposite quadrants will be shielded by foil and served as control, the third quadrant will be exposed to low intensity red laser (at 3 J/cm¬2), and the fourth quadrant will be exposed to high intensity red light (at 37 J/cm¬2). Treatments will be given twice weekly for 10 weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment.

Outcomes

Primary Outcome Measures

Change in the modified VASI score compared to baseline.

Secondary Outcome Measures

Full Information

First Posted
February 4, 2013
Last Updated
June 30, 2015
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT01787708
Brief Title
Efficacy of Red Light in Vitiligo
Official Title
Efficacy of Red Light in Vitiligo: A Prospective, Single-Blind Randomized Controlled Trial
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

Data Monitoring Committee
No

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. Visible red light has been shown to stimulates melanocyte migration and proliferation resulting in repigmentation of vitiligo patches. However, there are only a few studies published on the efficacy of red light in vitiligo. This is a prospective single-blind randomized clinical trial to assess efficacy of red light 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. Visible red light has been shown to stimulates melanocyte migration and proliferation resulting in repigmentation of vitiligo patches. However, there are only a few studies published on the efficacy of red light in vitiligo. The investigators plan on conducting a prospective single-blind randomized clinical trial to assess efficacy of red light in the treatment of vitiligo. Study Objective To evaluate the potential for red light to induce repigmentation within vitiligo patches.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
Vitiligo, red, laser, light

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
Low intensity red laser
Arm Type
Active Comparator
Arm Description
Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into four quadrants. Two opposite quadrants will be shielded by foil and served as control, the third quadrant will be exposed to low intensity red laser (at 3 J/cm¬2), and the fourth quadrant will be exposed to high intensity red light (at 37 J/cm¬2). Treatments will be given twice weekly for 10 weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment.
Arm Title
High intensity red light
Arm Type
Active Comparator
Arm Description
Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into four quadrants. Two opposite quadrants will be shielded by foil and served as control, the third quadrant will be exposed to low intensity red laser (at 3 J/cm¬2), and the fourth quadrant will be exposed to high intensity red light (at 37 J/cm¬2). Treatments will be given twice weekly for 10 weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment.
Arm Title
No treatment1 (covered)
Arm Type
No Intervention
Arm Description
Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into four quadrants. Two opposite quadrants will be shielded by foil and served as control, the third quadrant will be exposed to low intensity red laser (at 3 J/cm¬2), and the fourth quadrant will be exposed to high intensity red light (at 37 J/cm¬2). Treatments will be given twice weekly for 10 weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment.
Arm Title
No treatment2 (covered)
Arm Type
No Intervention
Arm Description
Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into four quadrants. Two opposite quadrants will be shielded by foil and served as control, the third quadrant will be exposed to low intensity red laser (at 3 J/cm¬2), and the fourth quadrant will be exposed to high intensity red light (at 37 J/cm¬2). Treatments will be given twice weekly for 10 weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment.
Intervention Type
Procedure
Intervention Name(s)
Red light
Primary Outcome Measure Information:
Title
Change in the modified VASI score compared to baseline.
Time Frame
assessments at 2, 4, 6, 8 and 10 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
16048754111
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 Lui, MD FRCPC
Phone
16048754111
Email
harvey.lui@ubc.ca
First Name & Middle Initial & Last Name & Degree
Harvey Lui, MD FRCPC

12. IPD Sharing Statement

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Efficacy of Red Light in Vitiligo

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