Clinical trial NCT01787708: Efficacy of Red Light in Vitiligo
Official title: Efficacy of Red Light in Vitiligo: A Prospective, Single-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Vitiligo
Keywords: Vitiligo
red
laser
light
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-02-11
Enrollment: 16
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in the modified VASI score compared to baseline.
timeFrame: assessments at 2, 4, 6, 8 and 10 weeks during treatment then at 4, 8, and 12 weeks post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: The Skin Care Center, Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Harvey Lui, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: