UVA 1 Phototherapy for Vitiligo | NCT01787695

Studies
UVA 1 Phototherapy for Vitiligo

NCT01787695

Sponsor

University of British Columbia

Status

Unknown status

Last Update Posted

Jul 2, 2015Estimated

Enrollment

16Estimated

Phase

Phase 2

Conditions

Vitiligo

Interventions

UVA1

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Dec 2015Estimated

Completion Date

Not provided

First Submitted Date

Feb 4, 2013

First Submission Date that Met QC Criteria

Feb 6, 2013

First Posted Date

Feb 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2015

Last Update Posted Date

Jul 2, 2015Estimated

Description Module

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No treatment (covered)	No Intervention
UVA1	Active Comparator		Procedure: UVA1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
UVA1	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Harvey Lui, MD, FRCPC	Contact	17788595522		harvey.lui@ubc.ca

Overall Officials

Name	Affiliation	Role
Harvey Lui, MD, FRCPC	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Skin Care Center, Vancouver General Hospital	Recruiting	Vancouver	British Columbia	V5Z 4E8	Canada

Condition Browse Module

MeSH Terms

ID	Term
D014820	Vitiligo

Ancestor Terms

ID	Term
D017496	Hypopigmentation
D010859	Pigmentation Disorders
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

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Browse Branches

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