Recruiting
Phase 2

UVA 1 Phototherapy

Sponsor:

University of British Columbia

Code:

NCT01787695

Conditions

Vitiligo

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

UVA1

Study Details

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.

Conditions

Vitiligo

Study ID

NCT01787695

Start date

Feb, 2013

Status verified date

Jun, 2015

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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 Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: No treatment (covered)

active comparator: UVA1

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Harvey Lui, MD, FRCPC

17788595522harvey.lui@ubc.ca

Locations

The Skin Care Center, Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E8

Contacts

Harvey I Lui, MD FRCPC

16048754111harvey.lui@ubc.ca

Principal Investigator:

Harvey Lui, MD FRCPC

More Information

Sponsor

University of British Columbia

Last update posted

Jul 2, 2015

Last verified

Jun, 2015

Keywords

  • Vitiligo
  • UVA1
  • Phototherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by University of British Columbia on 2015-07-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.