Trial record 10 of 41 for:    Open Studies | "Alopecia"

Excimer Light for Alopecia Areata

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01802177
First received: February 20, 2013
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Alopecia Areata
Procedure: UVB excimer light
Phase 2

Study Type: Interventional
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

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 18
Study Start Date: February 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802177

Contacts
Contact: Mohammed I AlJasser, MD, FRCPC 17788595522 mj_derma@hotmail.com

Locations
Canada, British Columbia
The Skin Care Center, Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 4E8
Contact: Mohammed I AlJaaser, MD FRCPC    17788595522    mj_derma@hotmail.com   
Principal Investigator: Harvey Lui, MD FRCPC         
Sponsors and Collaborators
University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01802177     History of Changes
Other Study ID Numbers: H12-02840
Study First Received: February 20, 2013
Last Updated: February 28, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Alopecia areata
Excimer
UVB

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hair Diseases
Hypotrichosis
Pathological Conditions, Anatomical
Skin Diseases

ClinicalTrials.gov processed this record on October 20, 2014