Excimer Light for Alopecia Areata

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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

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

        1. To evaluate the potential for UVB excimer light to induce hair regrowth within AA
           patches.

        2. To assess the side effect profile of UVB excimer light when used in the treatment of AA.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

 Change in hair count and caliber in each half

Condition

Alopecia Areata

Intervention

UVB excimer light

Study Arms / Comparison Groups

 UVB excimer light
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

18

Start Date

February 2013


Primary Completion Date

October 2015

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.
      

Gender

All

Ages

19 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Harvey Lui, MD FRCPC, 16048754111, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT01802177

Organization ID

H12-02840


Responsible Party

Sponsor

Study Sponsor

University of British Columbia


Study Sponsor

Harvey Lui, MD FRCPC, Principal Investigator, University of British Columbia


Verification Date

June 2015