Efficacy of Red Light in Vitiligo

Efficacy of Red Light in Vitiligo: A Prospective, Single-Blind Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Vitiligo
• Intervention / Treatment: Procedure: Red light

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.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E8
      • Recruiting
      • The Skin Care Center, Vancouver General Hospital
      • Contact: Harvey Lui, MD FRCPC; Phone Number: 16048754111; Email: harvey.lui@ubc.ca
      • Principal Investigator: Harvey Lui, MD FRCPC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low intensity red laser; 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.	Procedure: Red light
Active Comparator: High intensity red light; 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.	Procedure: Red light
No Intervention: No treatment1 (covered); 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.
No Intervention: No treatment2 (covered); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in the modified VASI score compared to baseline.	assessments at 2, 4, 6, 8 and 10 weeks during treatment then at 4, 8, and 12 weeks post treatment

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Harvey Lui, MD, FRCPC, University of British Columbia

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: February 4, 2013
• First Submitted That Met QC Criteria: February 6, 2013
• First Posted (Estimate): February 11, 2013

Study Record Updates

• Last Update Posted (Estimate): July 2, 2015
• Last Update Submitted That Met QC Criteria: June 30, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: laser; Vitiligo; red; light
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: H10-02235b