to determine the effect of different pulse durations on the efficacy of long-pulsed Alexandrite-assisted hair removal
Design
A single blind , randomized clinical trial with a split-face design of 50 subjects with blinded outcome assessment ,single center, community-based,randomization is by use of permuted block randomization
Settings and conduct
Patients go to the Razi hospital every 5 weeks and each session undergo a laser beam therapy using 3 and 10 msec pulse duration on each side of face
Participants/Inclusion and exclusion criteria
Inclusion criteria :
Age 18 years and above;
female patients with bilateral facial hirsutism
Exclusion criteria:
patients recieved any drug for hirsutism in last 3 months;
severe photosensivity;
keloidal or hypersensitivity scar tendency;
recent sun exposure ;
pregnancy;
lactation
Intervention groups
This is going to be a split-face study and for each patient,one half of face will be test and the other half will be the control.In fact half of the face (that will be chosen randomly) will be treated by 10 msec pulse duration and the other half will undergo treatment with 3 msec pulse duration.
Main outcome variables
The percentage of hair regrowth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191228045917N1
Registration date:2020-04-17, 1399/01/29
Registration timing:prospective
Last update:2020-04-17, 1399/01/29
Update count:0
Registration date
2020-04-17, 1399/01/29
Registrant information
Name
Parvaneh Hatami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5560 9951
Email address
p-hatami@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-06, 1399/03/17
Expected recruitment end date
2020-10-08, 1399/07/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of different pulse durations on the efficacy of long-pulsed Alexandrite-assisted hair removal,A split-face comparison study
Public title
Effect of pulse duration on laser-assisted hair removal
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 18 and above
facial hirsutism with clinical diagnosis by a dermatologist
Exclusion criteria:
in the last 3 months has not recieved any drug for hirsutism
severe photosensitivity
keloidal or hypertrophic scar tendency
recent sun exposure
pregnancy or lactation
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
2
one side is beamed by 3 msec pulse duration and the other side by 10 msec
Randomization (investigator's opinion)
Randomized
Randomization description
ّFor random allocation of treatment with two different settings ( pulse duration : 3 versus 10 msec), at first, face of subject is divided to 2 parts (right and left),then we generate 50 (number of our subjects) random samples with block randomization with considering 2 treatments and 4,6 and 8 blocks .Finally , we consider one side of face (that is chosen randomly) constant and based on random sequence generated, allocate the treatment with 10 msec pulse duration to that side of face.It is obvious that the other side will undergo treatment with 3 msec pulse duration.
For generation of random sequence , we will use an online software with this address :
https://www.sealedenvelope.com/simple-randomiser/v1/lists
Blinding (investigator's opinion)
Single blinded
Blinding description
our subjects will not know each side of their faces will be treated with which pulse duration.
two dermatologists that evaluate the photographs are also blinded about the allocation of pulse durations.
data analysis also will be done blindly
Placebo
Not used
Assignment
Parallel
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
2017-01-12, 1395/10/23
Ethics committee reference number
IR.TUMS.VCR.REC.1395.143
Health conditions studied
1
Description of health condition studied
Hirsutism
ICD-10 code
L68.0
ICD-10 code description
Hirsutism
Primary outcomes
1
Description
The percentage of hair regrowth
Timepoint
at sessions 5,10,15 weeks , the percentage of hair regrowth is measured
Method of measurement
by photographic evaluation by 2 other dermatologists
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: using the manufacture-recommended methods and settings, one side of the face of each patient (randomly determinded) is treated with a 10 msec pulse duration using an alexandrite laser ( Gentlase Pro. ,Candela, USA).treatment is conducted every 5 weeks for 3 sessions.hair counts and photographs are obtained before treatment and 1 month postoperatively.This laser has a wavelength of 755 nm , a wide range of pulse duration (3 -300 msec) , ability to generate fluence up to 150 J/cm2 and different spotsizes (6 to 18 mm).
Category
Treatment - Devices
2
Description
control group: using the manufacture-recommended methods and settings, the other side of the face of each patient is treated with a 3 msec pulse duration using an alexandrite laser ( Gentlase Pro. ,Candela, USA).treatment is conducted every 5 weeks for 3 sessions.hair counts and photographs are obtained before treatment and 1 month postoperatively.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Pedram Nourmohamad Pour
Street address
Razi hospital,Wahdat-e-eslami Ave.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5561 8989
Email
normohamad@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pedram Nourmohamad Pour
Street address
Razi hospital,Wahdat-e-eslami Ave.
City
Tehran
Province
Tehran
Postal code
11963911
Phone
+98 21 5561 8989
Email
normohamad@razi.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
Zeynab Aryanian
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi hospital,Wahdat-e-eslami Ave.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5561 8989
Email
z_aryanian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pedram Nourmohamad pour
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi hospital,Wahdat-e-eslami Ave.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5561 8989
Email
normohamad@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvaneh Hatami
Position
specialist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi hospital,Wahdat-e-eslami Ave.
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5561 8989
Email
p-hatami@alumnus.tums.ac.ir
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 hirsutism.Any 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 Pedram Nourmohamad Pour Dermatologist Razi hospital, Wahdat-e-eslami Ave., Tehran, District 12 Phone number +98 9128240659 e mail : normohamad@razi.tums.ac.ir
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