Determine the effectiveness of 308-nm Excimer laser therapy in Patients with Alopecia Areata
Design
A randomized Clinical trial with single groups, community-based, non-blind
Settings and conduct
Patients go to Razi Hospital every week and each session undergo an laser beam therapy.Each session the dose of laser therapy increases by 50 mj. Also, in another lesion of patients a determined dose of corticosteroid will be administered monthly
Participants/Inclusion and exclusion criteria
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
Intervention groups
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
Main outcome variables
The percentage of hair regrowth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150923024147N1
Registration date:2019-02-04, 1397/11/15
Registration timing:prospective
Last update:2019-02-04, 1397/11/15
Update count:1
Registration date
2019-02-04, 1397/11/15
Registrant information
Name
maryam daneshpajooh
Name of organization / entity
Tehran university of medical scienses
Country
Iran (Islamic Republic of)
Phone
+98 21 5561 8989
Email address
daneshpj@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2019-08-06, 1398/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of 308-nm Xenon Chloride Excimer Laser on the Treatment of Patchy Alopecia Areata
Public title
Excimer Laser in Alopecia Areata
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
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
Randomization (investigator's opinion)
Randomized
Randomization description
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
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
No. 1, Poorsina Ave., Ghods Ave., Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-01-12, 1397/10/22
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.689
Health conditions studied
1
Description of health condition studied
Alopecia Areata
ICD-10 code
L63
ICD-10 code description
Alopecia areata
Primary outcomes
1
Description
The percentage of hair regrowth
Timepoint
At sessions 4, 8, 12, the percentage of hair regrowth is measured.
Method of measurement
1.By phototrichogram(fotofinder) device. 2.by Photographic evaluation by 2 other dermatologists 3.By general assessment of the patient
Secondary outcomes
empty
Intervention groups
1
Description
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 milijoule and increases by as much as 50 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, we start the dose by 10% less than the previous dose.
Category
Treatment - Devices
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Maryam Daneshpazhooh
Street address
Razi hospital, Wahdat-e-Islami Ave., Tehran, District 12
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5560 9951
Email
razihospital@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Daneshpazhooh
Street address
Razi hospital, Wahdat-e-Islami Ave., Tehran, District 12
City
Tehran
Province
Tehran
Postal code
tel:1199663911
Phone
+98 21 5561 8989
Email
maryamdanesh.pj@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nika Kianfar
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Razi hospital, Wahdat-e-Islami Ave., Tehran, District 12
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5561 8989
Email
Nika_kianfar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Daneshpazhooh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi hospital, Wahdat-e-Islami Ave., Tehran, District 12
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5560 9951
Email
maryamdanesh.pj@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nika Kianfar
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Razi hospital, Wahdat-e-Islami Ave., Tehran, District 12
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5561 8989
Email
Nika_kianfar@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All patient information can be shared without naming and identifying them.
When the data will become available and for how long
Details of the data are immediately available after publishing the results.
To whom data/document is available
All researchers and health professionals working in academic, scientific and medical institutions.
Under which criteria data/document could be used
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.
From where data/document is obtainable
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
What processes are involved for a request to access data/document
Information is available immediately after verifying that the applicant's circumstances are met by the competent authorities.