MedPath

UVA 1 Phototherapy for Vitiligo

Phase 2
Conditions
Vitiligo
Interventions
Procedure: UVA1
Registration Number
NCT01787695
Lead Sponsor
University of British Columbia
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. 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.

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
16
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
Read More
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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
UVA1UVA1-
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Assessment of side effects in each half including erythema, pruritus, and polymorphous light eruptionassessments at 2, 4, 6, and 8 weeks during treatment then at 4, 8, and 12 weeks post treatment

Trial Locations

Locations (1)

The Skin Care Center, Vancouver General Hospital

🇨🇦

Vancouver, British Columbia, Canada

© Copyright 2025. All Rights Reserved by MedPath