Efficacy of Red Light in Vitiligo

Vitiligo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01787708
• Other study ID #: H10-02235b
• Status: Recruiting
• Phase: Phase 2
• First received: February 4, 2013
• Last updated: June 30, 2015
• Start date: February 2013

Study information

• Verified date: June 2015
• Source: University of British Columbia
• Contact: Harvey Lui, MD, FRCPC
• Phone: 16048754111
• Email: harvey.lui[@]ubc.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitiligo

Intervention

Procedure:
• Red light

Locations

Country	Name	City	State
Canada	The Skin Care Center, Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No