Determination of efficacy and safety of alexandrite laser with two pulses of 5 and 100 milliseconds
Design
A clinical trial with two groups with single blinded parallel groups with a sample size of 30 people based on statistical software and divided into two groups by random block method.
Settings and conduct
This is a randomized, double-blind clinical trial, which is a prospective study. The study period will be from two years to 1398 to 1400. It will take up to 8 months for each case to have a laser and checkups.
The study site is Tehran Razi Dermatology Hospital
Participants/Inclusion and exclusion criteria
Participants over 15 years of age with skin type under 4 and no isotretinoin over the past year and no excessive laser hair removal in the axilla over the past 4 months
Intervention groups
the effect of two different pulses of laser hair removal
Main outcome variables
Determination of efficacy and safety of alexandrite laser with two pulses of 5 and 100 milliseconds
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191204045609N1
Registration date:2020-11-19, 1399/08/29
Registration timing:retrospective
Last update:2020-11-19, 1399/08/29
Update count:0
Registration date
2020-11-19, 1399/08/29
Registrant information
Name
elham taghizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8611 1937
Email address
elhamtaghizadeh609@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy and safety of alexandrite laser in removing Axilla hair with two pulses of 5 and 100Milliseconds
Public title
Comparison of the efficacy and safety of alexandrite laser in removing Axilla hair with two pulses of 5 and 100Milliseconds in patients admitted to Razi Hospital during the years 1398-1400
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 15
Skin type under 4
Exclusion criteria:
Pregnancy and lactation
Excessive laser hair removal done in the last 4 months
Isotretinoin use in the last year
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Right and left axila area
Randomization (investigator's opinion)
Randomized
Randomization description
Individual block randomization based on statistical software
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in the scheme are not given an explanation of the received pulse duration
Placebo
Not used
Assignment
Parallel
Other design features
Nothing
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Razi hospital vahdat ave
City
Tehran
Province
Tehran
Postal code
1199663911
Approval date
2019-08-28, 1398/06/06
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.439
Health conditions studied
1
Description of health condition studied
Determination of efficacy and safety of alexandrite laser with two pulses of 5 and 100 milliseconds
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Determination of efficacy and safety of alexandrite laser with two pulses of 5 and 100 millisecond
Timepoint
2019-2021
Method of measurement
Dermoscopy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The first intervention group on the left or right side of the axilla area, people referred to Razi Hospital, who according to the inclusion criteria, including not using laser hair removal for a year, and skin type less than3
Category
Other
2
Description
Intervention group: Second intervention group opposite group 1 people referred to Razi Hospital, who according to the inclusion criteria, including not using laser hair removal for a year, and skin type less than3
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Arghavan azizpour
Street address
Razi hospital vahdat ave
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5562 0300
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
Arghavan azizpour
Street address
Razi hospital vahdat ave
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
tums_edu@tums.ac.ir
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
Arghavan azizpour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi hospital vahdat ave
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5562 0300
Email
a63a@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arghavan azizpour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi hospital vahdat ave
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
0098 553556321
Email
azizpour63@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arghavan azizpour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi hospital vahdat eslami, ave
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5560 9951
Email
azizpour63@gmil.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 data are shareable
When the data will become available and for how long
All data are shareable 6 months after publishing the results.
To whom data/document is available
Researchers working in universities or science institutions or people working in industrial areas can receive the data or other documents on the study.
Under which criteria data/document could be used
The data or the other documents on the research can be used for systematic review or any other purpose provided by having legal permission from the owners of the study
From where data/document is obtainable
Dr.arghavan azizpour
mobile phone number:00989123178995
mail:Azizpour63@gmail.com
What processes are involved for a request to access data/document
Using the data or documents is possible after one month, provided having the legal permission of the owners of the study, by one of the authorized people.