Clinical trial NCT01787695: UVA 1 Phototherapy for Vitiligo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Vitiligo
Keywords: Vitiligo
UVA1
Phototherapy
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. 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.

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, and 8 weeks during treatment then at 4, 8, and 12 weeks post treatment
Secondary outcomes:
measure: Assessment of side effects in each half including erythema, pruritus, and polymorphous light eruption
timeFrame: assessments at 2, 4, 6, and 8 weeks during treatment then at 4, 8, and 12 weeks post treatment
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: