Excimer Light for Alopecia Areata

Alopecia Areata Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01802177
• Other study ID #: H12-02840
• Status: Recruiting
• Phase: Phase 2
• First received: February 20, 2013
• Last updated: June 30, 2015
• Start date: February 2013

Study information

• Verified date: June 2015
• Source: University of British Columbia
• Contact: Harvey Lui, MD, FRCPC
• Phone: 16048754111
• Email: harvey.lui[@]ubc.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

Procedure:
• UVB excimer light

Locations

Country	Name	City	State
Canada	The Skin Care Center, Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in hair count and caliber in each half		at 6, 12, and 16 weeks from baseline	No
Secondary	Assessment of side effects in each half		at 6, 12, and 16 weeks from baseline	Yes