Clinical trial NCT01802177: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alopecia Areata
Keywords: Alopecia areata
Excimer
UVB
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in the percentage of hair regrowth for each half. We will consider the treamtment successful if there was ≥50% hair regrowth from baseline.
timeFrame: at 6, 12, and 16 weeks from baseline
Secondary outcomes:
measure: Change in hair count and caliber in each half
timeFrame: at 6, 12, and 16 weeks from baseline
measure: Assessment of side effects in each half
timeFrame: at 6, 12, and 16 weeks from baseline
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: The Skin Care Center, Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Harvey Lui, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: