Protocol summary
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Study aim
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Determine the effectiveness of 308-nm Excimer laser therapy in Patients with Alopecia Areata
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Design
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A randomized Clinical trial with single groups, community-based, investigator-blinded
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Settings and conduct
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Patients go to Razi Hospital every week and each session undergo an laser beam therapy.Each session the dose of laser therapy increases by 100 mj. Also, in another lesion of patients a determined dose of corticosteroid will be administered monthly
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1.Age 18-60 years
2.alopecia areata with clinical diagnosis by a dermatologist
3.Have at least 2 lesions or more (multi-patchy) in the face or scalp
4.lesion size at least 2 cm in 2 cm
5.In the last 3 months, has not recieved any drug for the hair loss
Non-inclusion criteria:
1.Progressive alopecia areata during the clinical trial
2.Having Other types of alopecia such as Totalis or universalis or ophiasis
3.Pregnancy and breastfeeding when entering the study
4.Any other cause of hair loss other than alopecia areata
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Intervention groups
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Patients' lesions are divided into 2 groups. One group is exposed to the excimer laser and the other group is undergone the influence of corticosteroid therapy
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Main outcome variables
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Percentage of hair regrowth according to clinical photographs as gross hair regrowth and also according to phototrichogram pictures concerning dermoscopic characteristics of the disease
General information
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Reason for update
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Upon completion of the study, additional information was entered. The start and end dates of the patient recruitment and study were completed. In the blinding section, the evaluators were unaware of the allocation of study groups and rated the outcomes blindly. The main treatment variable was also written in more detail.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150923024147N1
Registration date:
2019-02-04, 1397/11/15
Registration timing:
prospective
Last update:
2021-05-02, 1400/02/12
Update count:
1
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Registration date
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2019-02-04, 1397/11/15
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-04-04, 1398/01/15
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Expected recruitment end date
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2019-08-06, 1398/05/15
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Actual recruitment start date
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2019-07-29, 1398/05/07
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Actual recruitment end date
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2020-02-01, 1398/11/12
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Trial completion date
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2020-05-25, 1399/03/05
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Scientific title
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Comparison of the Effectiveness of 308-nm Xenon Chloride Excimer Laser on the Treatment of Patchy Alopecia Areata
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Public title
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Excimer Laser in Alopecia Areata
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
clinical diagnosis of alopecia areata by a dermatologist
Having at least 2 lesions or more (multiple-patchy) in the face or scalp
The size of the lesions is at least 2 cm in 2 cm
has not used a drug for the lesions, In the last 3 months
Exclusion criteria:
Having alopecia totalis or alopecia universalis or ophiasis
Pregnancy breast feeding
An underlying disease such as endocrine diseases or immonological disorders causes hair loss
If hair loss has a cause other than alopecia areata.
Taking a drug (systemically or topical) causes hair loss or hair regrowth in the last 3 months
Surgical treatment such as hair transplantation for the treatment of hair loss.
Any dermatological diseases such as skin cancer, infection which can cause hair loss
Photosensivity
If the patient becomes pregnant during the study
patients unwillingness to continue cooperation in the clinical trial
Progression of disease during the clinical trial
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
35
More than 1 sample in each individual
Number of samples in each individual:
2
one lesion is beamed by excimer laser and one lesion is injection with tramcinolone 5mg/ml
Actual sample size reached:
16
More than 1 sample in each individual
Actual sample size in each individual:
6
alopecic patches in each person
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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One of the lesions that has the inclusion criteria is undergone the beam of excimer radiation by use of permuted block randomization. And one of the other lesions is considered as a control for steroid injection
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Two dermatologists evaluated the photographs and phototrichograms of three assessments of the baseline, after the last treatment session, and after one month of follow-up blindly.
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-01-12, 1397/10/22
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1397.689
Health conditions studied
1
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Description of health condition studied
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Alopecia Areata
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ICD-10 code
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L63
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ICD-10 code description
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Alopecia areata
Primary outcomes
1
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Description
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The percentage of hair regrowth
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Timepoint
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At at baseline, after the last treatment session (session 12); and after one month of follow-up, the percentage of hair regrowth is measured.
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Method of measurement
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1.By phototrichogram(fotofinder) device. 2.by Photographic evaluation by 2 other dermatologists 3.By general assessment of the patient
Intervention groups
1
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Description
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Intervention group: another category of the lesions are treated with an excimer laser treatmentThe patient will visit the center for 12 sessions (once a week). In each session, the patient's lesion that was selected based on the initial blockage, is irradiated by the excimer laser beam .The laser start dose is 100 to 200 milijoule, depending on the skin type and increases by as much as 100 milijoule per square centimeter in each volume. In the event of complications such as laser-induced burns, the laser treatment of that session is discontinued and after the necessary steps and treatment with topical steroids in the next session, the dosage would be reduced by 100 mJ in the next session
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Category
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Treatment - Devices
2
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Description
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Control group: Patients' lesions are divided into two groups: one treatment group, corticosteroid injections (40 mg/ml triamcinolone acetonide diluted with lidocaine or distilled water) are treated monthly with 5 mg/ml in 3 sessions(once a month) for the patient.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All patient information can be shared without naming and identifying them.
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When the data will become available and for how long
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Details of the data are immediately available after publishing the results.
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To whom data/document is available
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All researchers and health professionals working in academic, scientific and medical institutions.
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Under which criteria data/document could be used
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The data is only shared for person whose purpose is to improve the therapeutic course of alopecia areata.
Any The type of statistical analysis can be done in order to improve the treatment.
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From where data/document is obtainable
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Tehran University of Medical Sciences
professor Maryam Daneshpazhooh
Dermatologist
Razi hospital, Wahdat-e-Islami Ave., Tehran, District 12
Phone number:
+98 912 130 6662
Email: maryamdanesh.pj@gmail.com
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What processes are involved for a request to access data/document
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Information is available immediately after verifying that the applicant's circumstances are met by the competent authorities.
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Comments
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