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Excimer Light for Alopecia Areata

Primary Purpose

Alopecia Areata

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
UVB excimer light
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring Alopecia areata, Excimer, UVB

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18 years.
  • Subject has a patch of at least 12 cm2 on the scalp with no evidence of hair regrowth.
  • Subject is willing and capable of cooperating to the extent and degree required by the protocol.

Exclusion Criteria:

  • Patients who received treatment for alopecia areata within the past 4 weeks.
  • Patients with alopecia totalis or alopecia universalis.
  • Patients with known photosensitivity like having polymorphous light eruption, connective tissue diseases, porphyria or Xeroderma pigmentosum.
  • Pregnancy or breast-feeding.
  • History of previous skin cancer.
  • Patients that have participated in another investigational drug or device study within 30 days of enrollment.

Sites / Locations

  • The Skin Care Center, Vancouver General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

UVB excimer light

No treatment (covered)

Arm Description

Patches of alopecia will be treated twice weekly with UVB excimer light. Only one half of a single alopecia areata patch will be treated. In order to treat the same half during each visit, a transparent sheet will be marked, using a marking pen, to delineate the borders of the treatment area with a central dividing line. The other half will be covered and used as a control. Treatments will be given randomly (by sealed envelope randomization method) into one of the two halves in different patients but will be given into the same half in each patient in all treatment sessions. Only one investigator will know the intervention each half has received. A total of 23 treatments will be given over 12 weeks.

Outcomes

Primary Outcome Measures

Change in the percentage of hair regrowth for each half. We will consider the treamtment successful if there was ≥50% hair regrowth from baseline.

Secondary Outcome Measures

Change in hair count and caliber in each half
Assessment of side effects in each half

Full Information

First Posted
February 20, 2013
Last Updated
June 30, 2015
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT01802177
Brief Title
Excimer Light for Alopecia Areata
Official Title
Efficacy and Safety of UVB Excimer Light in Alopecia Areata: A Prospective, Single-Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Alopecia Areata (AA) is a chronic autoimmune inflammatory disease causing nonscarring hair loss. Many treatment modalities have been found to be helpful in AA, however, none on them cure the disease. UVB excimer light has recently emerged as a new therapeutic modality in many dermatologic diseases. There are no prospective randomized controlled trials evaluating the efficacy and safety of UVB excimer light in AA. We plan on conducting a prospective split lesion single-blinded randomized clinical trial to assess efficacy and safety of UVB excimer light in the treatment of AA.
Detailed Description
Alopecia Areata (AA) is a chronic autoimmune inflammatory disease causing nonscarring hair loss. Many treatment modalities have been found to be helpful in AA, however, none on them cure the disease. Excimer laser has been shown to be effective in the treatment of AA in controlled studies. The main disadvantage of the previous studies evaluating excimer laser is choosing separate patches as a control which does not account for interlesional treatment response variability. UVB excimer light has recently emerged as a new therapeutic modality in many dermatologic diseases. However, there are only a few studies that evaluated the efficacy and safety of UVB excimer light in AA. Those studies have shown that UVB excimer light is effective in the treatment of AA but none of them was conducted in a controlled fashion. There are no prospective randomized controlled trials evaluating the efficacy and safety of UVB excimer light in AA. We plan on conducting a prospective split lesion single-blinded randomized clinical trial to assess efficacy and safety of UVB excimer light in the treatment of AA. Study Objectives To evaluate the potential for UVB excimer light to induce hair regrowth within AA patches. To assess the side effect profile of UVB excimer light when used in the treatment of AA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
Alopecia areata, Excimer, UVB

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UVB excimer light
Arm Type
Experimental
Arm Description
Patches of alopecia will be treated twice weekly with UVB excimer light. Only one half of a single alopecia areata patch will be treated. In order to treat the same half during each visit, a transparent sheet will be marked, using a marking pen, to delineate the borders of the treatment area with a central dividing line. The other half will be covered and used as a control. Treatments will be given randomly (by sealed envelope randomization method) into one of the two halves in different patients but will be given into the same half in each patient in all treatment sessions. Only one investigator will know the intervention each half has received. A total of 23 treatments will be given over 12 weeks.
Arm Title
No treatment (covered)
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
UVB excimer light
Primary Outcome Measure Information:
Title
Change in the percentage of hair regrowth for each half. We will consider the treamtment successful if there was ≥50% hair regrowth from baseline.
Time Frame
at 6, 12, and 16 weeks from baseline
Secondary Outcome Measure Information:
Title
Change in hair count and caliber in each half
Time Frame
at 6, 12, and 16 weeks from baseline
Title
Assessment of side effects in each half
Time Frame
at 6, 12, and 16 weeks from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 years. Subject has a patch of at least 12 cm2 on the scalp with no evidence of hair regrowth. Subject is willing and capable of cooperating to the extent and degree required by the protocol. Exclusion Criteria: Patients who received treatment for alopecia areata within the past 4 weeks. Patients with alopecia totalis or alopecia universalis. Patients with known photosensitivity like having polymorphous light eruption, connective tissue diseases, porphyria or Xeroderma pigmentosum. Pregnancy or breast-feeding. History of previous skin cancer. Patients that have participated in another investigational drug or device study within 30 days of enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Harvey Lui, MD, FRCPC
Phone
16048754111
Email
harvey.lui@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harvey Lui, MD FRCPC
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Skin Care Center, Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harvey Lui, MD FRCPC
Phone
16048754111
Ext
68691
Email
harvey.lui@ubc.ca
First Name & Middle Initial & Last Name & Degree
Harvey Lui, MD FRCPC

12. IPD Sharing Statement

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Excimer Light for Alopecia Areata

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