- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01802177
Excimer Light for Alopecia Areata
Efficacy and Safety of UVB Excimer Light in Alopecia Areata: A Prospective, Single-Blind Randomized Controlled Trial
Study Overview
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
- 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Harvey Lui, MD, FRCPC
- Phone Number: 16048754111
- Email: harvey.lui@ubc.ca
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E8
- Recruiting
- The Skin Care Center, Vancouver General Hospital
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Principal Investigator:
- Harvey Lui, MD FRCPC
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Contact:
- Harvey Lui, MD FRCPC
- Phone Number: 68691 16048754111
- Email: harvey.lui@ubc.ca
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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No Intervention: No treatment (covered)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: at 6, 12, and 16 weeks from baseline
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at 6, 12, and 16 weeks from baseline
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in hair count and caliber in each half
Time Frame: at 6, 12, and 16 weeks from baseline
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at 6, 12, and 16 weeks from baseline
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Assessment of side effects in each half
Time Frame: at 6, 12, and 16 weeks from baseline
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at 6, 12, and 16 weeks from baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Harvey Lui, MD FRCPC, University of British Columbia
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H12-02840
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alopecia Areata
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Eli Lilly and CompanyRecruitingSkin Diseases | Pathological Conditions, Anatomical | Alopecia | Hypotrichosis | Hair Diseases | Areata AlopeciaUnited States, Taiwan, Japan, Spain, Korea, Republic of, Germany, France, Mexico, Canada, Poland, Australia, Hungary, Argentina
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Suzhou Zelgen Biopharmaceuticals Co.,LtdActive, not recruitingAlopecia Areata(AA)China
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University Hospital, RouenCompletedALOPECIA AREATAFrance
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Services Institute of Medical Sciences, PakistanCompletedExtensive Alopecia AreataPakistan
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Inmagene LLCRecruitingAlopecia Areata (AA)United States, Canada
-
Yale UniversityCompletedAlopecia Areata (AA) | Alopecia Totalis (AT) | Alopecia Universalis (AU)United States
-
Siriraj HospitalCompletedRecalcitrant Alopecia Totalis | Recalcitrant Alopecia UniversalisThailand
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EquilliumWithdrawnAlopecia Areata | Alopecia Totalis | Alopecia Universalis
-
Lindsey BordoneWithdrawnAlopecia Areata | Alopecia Totalis | Alopecia Universalis
-
Aclaris Therapeutics, Inc.Completed
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-
University of Texas Southwestern Medical CenterCompleted
-
Clinuvel, Inc.Recruiting
-
Phoenix Children's HospitalWithdrawn
-
Clinuvel Pharmaceuticals LimitedCompleted
-
University of NottinghamCompleted
-
University of PennsylvaniaPfizerCompleted