Evaluation of efficacy of combined topical Bimatoprost and Fractionated carbon dioxide laser versus Bimatoprost alone in treatment of alopecia areata patients
Determining the effectiveness of topical bimatoprost with fractional carbon dioxide laser in comparison with topical bimatoprost alone in the treatment of patients with alopecia areata
Design
Triple-blind clinical trial, with parallel, randomized groups, for easy randomization using Minitab 16 software
Settings and conduct
This study will be performed on alopecia areata patients referred to Afzalipour Hospital in Kerman. Twenty patients with two alopecia patches in scalp will be randomly placed in one carbon dioxide laser with bimatoprost and in the other patch only bimatoprost. Patient, data analyzer,The person evaluating the response to treatment are unaware of the type of treatment.
Participants/Inclusion and exclusion criteria
Alopecia areata patient who has two similar patches on the scalp
Alopecia areata patients treated in the last three months are not included in the study
pregnant or breastfeeding patient not included in the study
The patient with a history of allergy to prostaglandin analogues is not included in the study
Intervention groups
first group : bimatoprost plus co2 fractional laser
second group : bimatoprost alone
Main outcome variables
Percentage of recovery based on lesion area according to SALT Score, patient satisfaction based on 7 Point global-assessment scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210715051895N1
Registration date:2021-09-21, 1400/06/30
Registration timing:registered_while_recruiting
Last update:2021-09-21, 1400/06/30
Update count:0
Registration date
2021-09-21, 1400/06/30
Registrant information
Name
Alireza Safari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 8328
Email address
safarialireza111@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of combined topical Bimatoprost and Fractionated carbon dioxide laser versus Bimatoprost alone in treatment of alopecia areata patients
Public title
Evaluation of efficacy of combined topical Bimatoprost and Fractionated carbon dioxide laser versus Bimatoprost alone in treatment of alopecia areata
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Alopecia areata patients who have two similar alopecia patches on the scalp
Exclusion criteria:
pregnancy
lactation
history of allergy to prostaglandin analouge
Taking medication or treatment for the past three months that affects the hair cycle
Uncontrolled systemic disease
Non-patchy alopecia areata and involving area other than the scalp
photosensivity
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Two similar alopecia patches in each individual, one treated with fractional carbon dioxide laser with topical bimatoprost and the other patch treated only with topical bimatoprost
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done using the random number table method. The table consists of numbers from one to one hundred and without a specific pattern or order and is made completely randomly. Then the numbers are touched randomly with their eyes closed. If the number is even, the treatment with bimatoprost is performed alone and if the number is odd, the combined treatment of carbon dioxide laser with bimatoprost is performed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Ebne Sina Ave; Tahmasb Abad Blvd.
City
Kerman
Province
Kerman
Postal code
761614111
Approval date
2021-05-30, 1400/03/09
Ethics committee reference number
IR.KMU.REC.1400.112
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
Alopecia patch area
Timepoint
at base line ,4,8,12,24 weeks later
Method of measurement
Measurement of hair regrowth rate by physical examination based on Salt score scale
2
Description
Patient satisfaction
Timepoint
4,8,12,24 weeks later
Method of measurement
By 7point global-assessment patient satisfaction questionnaire
Secondary outcomes
1
Description
Erythema
Timepoint
4,8,12 Weeks from the beginning of treatment
Method of measurement
By clinical examination and classification of severity of complications into mild, moderate and severe
2
Description
Scaling
Timepoint
4,8,12 Weeks from the beginning of treatment
Method of measurement
By clinical examination and classification of severity of complications into mild, moderate and severe
3
Description
skin dryness
Timepoint
4,8,12 Weeks from the beginning of treatment
Method of measurement
By clinical examination and classification of severity of complications into mild, moderate and severe
4
Description
Pruritis
Timepoint
4,8,12 Weeks from the beginning of treatment
Method of measurement
By clinical examination and classification of severity of complications into mild, moderate and severe
Intervention groups
1
Description
Intervention group: Combination therapy with CO2 laser and topical bimatoprost.03%. How to use: Fractional CO2 laser treatment is performed once every two weeks for three months and immediately after the laser and also between laser sessions, the patient will use 0.03% topical bimatoprost twice a day. For CO2 laser, local anesthesia (EMLA cream) is performed with a closed dressing for one hour before the laser and then the desired area is sterilized with 70 ° alcohol and a fractional CO2 laser with the following settings is used: DEKA;Italy;fractional scanning mode;one pulse;spot size=15mm;power=5w;dwell time=500ms;smart stack=3;spacing=700microm;density8.7%;fluence=4.68j/cm2;energy=51.6mj . The patient will receive topical bimatoprost .03% (EXCILIA .03% 3ml sterile solution, IRAN, INOCLON) twice a day, with a cotton applicator in the area of alopecia patch for three months.
Category
Treatment - Drugs
2
Description
Control group: The patient will receive topical bimatoprost .03% (EXCILIA .03% 3ml sterile solution, IRAN, INOCLON) twice a day, with a cotton applicator in the area of alopecia patch for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Simin Shamsi Meymandi
Street address
Afzalipour Hospital ,Imam khomeyni Ave; Kerman
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8328
Email
meymandi_s@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Ebnesina Ave; Jehad Blvd
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Simin Shamsimeymandi
Position
Professor of dermatology
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Afzalipour Hospital, Imam Khomeyni Ave; Kerman
City
Kerman
Province
Kerman
Postal code
761691391
Phone
+98 34 3132 8328
Email
meymandi_s@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Simin Shamsimeymandi
Position
Professor of dermatology
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Afzalipour Hospital, Imam Khomeyni Ave; Kerman
City
Kerman
Province
Kerman
Postal code
761691391
Phone
+98 34 3132 8328
Email
meymandi_s@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Simin Shamsimeymandi
Position
Professor of dermatology
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Afzalipour Hospital, Imam Khomeyni Ave; Kerman
City
Kerman
Province
Kerman
Postal code
761691391
Phone
+98 34 3132 8328
Email
meymandi_s@hotmail.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
Not applicable
Title and more details about the data/document
Primary and secondary outcome information is available
When the data will become available and for how long
Access starts five years after the results are published
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
After reviewing and approving the application by the researchers of this study, information will be available
From where data/document is obtainable
E-mail Alireza Safari
safarialireza111@gmail.com
What processes are involved for a request to access data/document
Examination of the application by the study researchers will be a maximum of two months process