Alopecia Areata | Excimer Light for Alopecia Areata
Alopecia Areata research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:UVB excimer light
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
UVB excimer lightPatches 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.
No treatment (covered)
Start Date: February 2013
Phase: Phase 2
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
Study sponsors, principal investigator, and references
Principal Investigator: Harvey Lui, MD FRCPC
Lead Sponsor: University of British Columbia