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UVA 1 Phototherapy for Vitiligo

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ClinicalTrials.gov Identifier: NCT01787695
Recruitment Status : Unknown
Verified June 2015 by University of British Columbia.
Recruitment status was:  Recruiting
First Posted : February 11, 2013
Last Update Posted : July 2, 2015
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Vitiligo Procedure: UVA1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2013
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in the modified VASI score compared to baseline. [ Time Frame: assessments at 2, 4, 6, and 8 weeks during treatment then at 4, 8, and 12 weeks post treatment ]

Secondary Outcome Measures :
  1. Assessment of side effects in each half including erythema, pruritus, and polymorphous light eruption [ Time Frame: assessments at 2, 4, 6, and 8 weeks during treatment then at 4, 8, and 12 weeks post treatment ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01787695


Contacts
Contact: Harvey Lui, MD, FRCPC 17788595522 harvey.lui@ubc.ca

Locations
Canada, British Columbia
The Skin Care Center, Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 4E8
Contact: Harvey I Lui, MD FRCPC    16048754111 ext 68691    harvey.lui@ubc.ca   
Principal Investigator: Harvey Lui, MD FRCPC         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Harvey Lui, MD, FRCPC University of British Columbia
More Information
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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01787695     History of Changes
Other Study ID Numbers: H10-02235
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: July 2, 2015
Last Verified: June 2015

Keywords provided by University of British Columbia:
Vitiligo
UVA1
Phototherapy

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases