Efficacy of Red Light in Vitiligo

• ClinicalTrials.gov Identifier: NCT01787708
• Recruitment Status: Unknown
• First Posted: February 11, 2013
• Last Update Posted: July 2, 2015
• Sponsor: University of British Columbia
• Information provided by (Responsible Party): University of British Columbia

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.

Condition or disease	Intervention/treatment	Phase
Vitiligo	Procedure: Red light	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Red Light in Vitiligo: A Prospective, Single-Blind Randomized Controlled Trial
• Study Start Date: February 2013
• Estimated Primary Completion Date: December 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Harvey Lui, MD, FRCPC; 16048754111; harvey.lui@ubc.ca

Locations

Canada, British Columbia

The Skin Care Center, Vancouver General Hospital; Recruiting

Vancouver, British Columbia, Canada, V5Z 4E8

Contact: Harvey Lui, MD FRCPC 16048754111 harvey.lui@ubc.ca

Principal Investigator: Harvey Lui, MD FRCPC

Sponsors and Collaborators

University of British Columbia

Investigators

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

More Information

• Responsible Party: University of British Columbia
• ClinicalTrials.gov Identifier: NCT01787708
• Other Study ID Numbers: H10-02235b
• First Posted: February 11, 2013
• Last Update Posted: July 2, 2015
• Last Verified: June 2015

Keywords provided by University of British Columbia:

Vitiligo; red; laser; light

Additional relevant MeSH terms:

Vitiligo; Hypopigmentation; Pigmentation Disorders; Skin Diseases