Investigate the efficacy and safety of single, repeated and diascopic Q-switched laser therapy in tattoo removal
Design
A non-randomized, single-arm, non-blinded
Settings and conduct
The study is conducted at Razi hospital.
Participants/Inclusion and exclusion criteria
Inclusion criterion: candidates for tattoo removal using Q-switched laser radiation.
Exclusion criteria: 1- colorful or faded tattoo 2- scars in the tattooed skin or area immediately surrounding it 3- unstable mental status 4- active infection 5- Pregnancy or lactation 6- History of an uncontrolled serious disorder.
Intervention groups
All the participants receive Q-switched laser radiation for three consecutive sessions six weeks apart. The tattooed lesion is divided into three parts. A 1/3 of the tattooed skin is treated with single Q-switched laser radiation in each session. The other 1/3 is received two laser radiations, 15 min apart. Finally, the last 1/3 part is treated with single laser radiation under diascopy.
Main outcome variables
Fading of the tattooed lesion with each intervention; the incidence of side effects with each treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180223038834N1
Registration date:2018-04-13, 1397/01/24
Registration timing:registered_while_recruiting
Last update:2018-04-13, 1397/01/24
Update count:0
Registration date
2018-04-13, 1397/01/24
Registrant information
Name
Darya Khosravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5561 8989
Email address
dkhosravi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison study of single, repeated and diascopic Q-switched laser therapy in tattoo removal in patients who referred to Razi Hospital
Public title
A comparison study of diascopic Q-switched laser therapy in tattoo removal
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
candidates for tattoo removal using Q-switched laser radiation
Exclusion criteria:
Colorful or faded tattoo
Scars in the tattooed skin or area immediately surrounding it
Unstable mental status
Active infection
Pregnancy or lactation
History of an uncontrolled serious disorder
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
N/A
Randomization description
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
Faculty of Medicine, Tehran University of Medical Sciences, Poursina st.
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2017-11-22, 1396/09/01
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.3959
Health conditions studied
1
Description of health condition studied
Tattoo pigmentation
ICD-10 code
L81.8
ICD-10 code description
Other specified disorders of pigmentation
Primary outcomes
1
Description
The fading of the tattooed lesion
Timepoint
18 weeks
Method of measurement
Percentage of tattoo fading in close-up photographs taken before and after initiation of the interventions
Secondary outcomes
1
Description
side-effects
Timepoint
18 weeks
Method of measurement
History and physical examination
Intervention groups
1
Description
Intervention group: The tattooed lesion is divided into three parts. A 1/3 of the tattooed skin is treated with single Q-switched laser radiation in each session. The other 1/3 is received two laser radiations, 15 min apart. Finally, the last 1/3 part is treated with single laser radiation under diascopy.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin Razi Hospital
Full name of responsible person
Darya Khosravi
Street address
Razi hospital, Razi Ave, Vahdate eslami Ave, Hafiz Street
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 5561 8989
Email
dkhosravi@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhound Zadeh
Street address
Research Vice-Chancellor, Room 205, First Floor, Education Building, Faculty of Medicine, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6640 0917
Email
s.akhond@neda.net
Web page address
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
Darya Khosravi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Razi hospital, Razi Ave, Vahdate eslami Ave, Hafiz Street
City
Teharn
Province
Tehran
Postal code
1417613151
Phone
+98 21 5561 8989
Email
dkhosravi@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Darya Khosravi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Razi hospital, Razi Ave, Vahdate eslami Ave, Hafiz Street
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 5561 8989
Email
dkhosravi@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Darya Khosravi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Razi hospital, Razi Ave, Vahdate eslami Ave, Hafiz Street
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 5561 8989
Email
dkhosravi@razi.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
IPD collected for the primary outcome measure only
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
Scientific research
From where data/document is obtainable
Dr. Darya Khosravi
What processes are involved for a request to access data/document
The application is sent by official university email which should contain the recipient's information and the purpose of his/her request. After having verified the accuracy of the information, files would be sent.