Excimer Light for Alopecia Areata

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of UVB Excimer Light in Alopecia Areata: A Prospective, Single-Blind Randomized Controlled Trial

Conditions
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Alopecia Areata

Intervention / Treatment
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* Procedure: UVB excimer light


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UVB excimer light<br>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<br> <br> |
| No Intervention: No treatment (covered)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the percentage of hair regrowth for each half. We will consider the treamtment successful if there was ≥50% hair regrowth from baseline. |  | at 6, 12, and 16 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hair count and caliber in each half |  | at 6, 12, and 16 weeks from baseline | 
| Assessment of side effects in each half |  | at 6, 12, and 16 weeks from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alopecia areata, Excimer, UVB