UVA 1 Phototherapy for Vitiligo

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. Ultraviolet A1 (UVA1) phototherapy has been shown to be useful for a variety of skin diseases. However, there are only a few studies published on the efficacy of UVA1 in vitiligo. This is a prospective single-blind randomized clinical trial to assess efficacy and safety of UVA1 in the treatment of vitiligo.

Study Overview

• Status: Unknown
• Conditions: Vitiligo
• Intervention / Treatment: Procedure: UVA1

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. Narrow-band UVB (NB-UVB) is currently the preferred treatment over topical psoralen and ultraviolet A radiation (PUVA), for patients with vitiligo. However, overall response of vitiligo to NB-UVB has been variable. Ultraviolet A1(UVA1) phototherapy is now useful for a variety of skin diseases, specifically scleroderma. There are only a few studies published on the efficacy of UVA1 in vitiligo.

One of the main side effects of UVA1 is prominent tanning which might be due to melanocyte stimulation. Therefore, the investigators hypothesis is that UVA1 will induce significant skin pigmentation to improve vitiligo. The investigators plan on conducting a prospective single-blind randomized clinical trial to assess efficacy and safety of UVA1 in the treatment of vitiligo.

Study Objectives

1. To evaluate the potential for UVA1 to induce repigmentation within vitiligo patches.
2. To assess the side effect profile of UVA1 when used in the treatment of vitiligo.

• 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
      • Principal Investigator: Harvey Lui, MD FRCPC
      • Contact: Harvey I Lui, MD FRCPC; Phone Number: 68691 16048754111; Email: harvey.lui@ubc.ca

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No treatment (covered)
Active Comparator: UVA1	Procedure: UVA1; Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into two halves. One half will be shielded by foil and served as control while the other half will be exposed to UVA1. The dose of UVA1 will be 60 J/cm2, 5 times a week for 4 weeks. Patients that have no or less than 10% pigmentation change after 4 weeks will receive UVA1 130J/cm2, 5 times a week for another 4 weeks. The patients with more than 10% pigmentation change will receive UVA1 60 J/cm2, 5times a week for another 4weeks. 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, and 8 weeks during treatment then at 4, 8, and 12 weeks post treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of side effects in each half including erythema, pruritus, and polymorphous light eruption	assessments at 2, 4, 6, and 8 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: Phototherapy; Vitiligo; UVA1
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: H10-02235