Excimer Light for Alopecia Areata
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of UVB Excimer Light in Alopecia Areata: A Prospective, Single-Blind Randomized Controlled Trial|
- 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 ] [ Designated as safety issue: No ]
- Change in hair count and caliber in each half [ Time Frame: at 6, 12, and 16 weeks from baseline ] [ Designated as safety issue: No ]
- Assessment of side effects in each half [ Time Frame: at 6, 12, and 16 weeks from baseline ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2013|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: UVB excimer light
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.
|Procedure: UVB excimer light|
|No Intervention: No treatment (covered)|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01802177
|Contact: Harvey Lui, MD, FRCPCfirstname.lastname@example.org|
|Canada, British Columbia|
|The Skin Care Center, Vancouver General Hospital||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 4E8|
|Contact: Harvey Lui, MD FRCPC 16048754111 ext 68691 email@example.com|
|Principal Investigator: Harvey Lui, MD FRCPC|
|Principal Investigator:||Harvey Lui, MD FRCPC||University of British Columbia|