To investigate the efficacy and safety of single pass Pulsed Dye Laser (PDL) with double pass Pulsed Dye Laser(PDL) ,within 20 minutes interval, for treatment of port wine stain(PWS)
To investigate the efficacy and safety of double pass Pulsed dye laser ( PDL) with single pass PDL in treating port wine stain(PWS)
Design
A concealed, randomized, non blinded, inter_patient placebo controlled clinical trial with a parallel group design of 23 patients.Block randomization has been done.
Settings and conduct
23 patient will treat in razi hospital with pulsed dye laser (PDL) ,in whole of lesion, every 4 weeks up to 3month(3 sessions) . The port wine stain (PWS )lesion is divided in two portion ( up and down ) in the same dermatome .one part randomly receive long pulse PDL laser:Pulse duration 20 and frequency 13 and after 20 minutes the whole lesion wil be treated with short pulse PDL laser :pulse duration 1.5 and frequency 11.Phothography (visoface) and photofinder before first PDL and 1month after last treatment will be done. Side effects of the procedure were also recorded at each session. three patient who have congenital PWS are included in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients who have congenital port wine stain and are older than 10 years
Exclusion criteria: patient who has treated PWS previously and children who can not tolerate PDL without general anesthesia
Intervention groups
Intervention group: Treatment of port wine stain (PWS) with Double pulse pulsed dye laser (PDL) , long pulse duration and short pulse duration within 20 minutes interval Control group : Treatment with short pulse PDL laser.
Main outcome variables
Degree of erythema ; side effects ( Purpura; hypopigmentation; hyperpigmentation; scar)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180815040808N1
Registration date:2019-02-02, 1397/11/13
Registration timing:registered_while_recruiting
Last update:2019-02-02, 1397/11/13
Update count:0
Registration date
2019-02-02, 1397/11/13
Registrant information
Name
Zahra Razavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5561 8989
Email address
razavi_z@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-30, 1397/11/10
Expected recruitment end date
2019-08-01, 1398/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To investigate the efficacy and safety of single pass Pulsed Dye Laser (PDL) with double pass Pulsed Dye Laser(PDL) ,within 20 minutes interval, for treatment of port wine stain(PWS)
Public title
Effect of double pass PDL in treatment of PWS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have congenital port wine stain are included in the study
Patients are at least 10 years old
Patients should fill the informed concent before inclusion in the study
Exclusion criteria:
Patients who have treated the port wine stain previously
Children who can not tolerate laser without general anesthesia
Age
From 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
23
More than 1 sample in each individual
Number of samples in each individual:
2
In every patient ,lesion will be divided to two part and use single pass in one part and double pass in another
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization
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 Tehran University of Medical Sciences
Street address
Vice-chancellor for Research of Tehran University of Medical Sciences, 205th room, 1st floor, Education Bldg, Poursina
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2018-05-23, 1397/03/02
Ethics committee reference number
IR. TUMS. MEDICINE. REC.1397.249
Health conditions studied
1
Description of health condition studied
Port wine stain
ICD-10 code
Q82.5
ICD-10 code description
Congenital non-neoplastic naevus
Primary outcomes
1
Description
Evaluation the degree of erythema of the lesion
Timepoint
Before starting the treatment and one month after the last (third) session of the laser
Method of measurement
photographs taken on months 0 and 1 month after last treatment and analyze with visioface device( to determine of reducing erythma in quantity) and photofinder (to evaluate the microscopic features of the vessels before treatment and evaluate the exact reduction in erythema quantity)
Secondary outcomes
1
Description
Laser side effects
Timepoint
Monthly
Method of measurement
According to physical exam and pictures
Intervention groups
1
Description
Intervention group 1 :Twenty three patients who have port wine stain included in the study.One part of the lesion which has been choosed randomly will recieve long pulse PDL laser with ( pulse duration 20 and fluence 13) .For example, Some of the patients will recieve the mentioned laser on the upper portion of the lesion, while others will recieve on the lower portion of the lesion. Patients will recieve laser in months 0,1&2.
Category
Treatment - Devices
2
Description
Intervention group2:The same twenty three patients recieve short pulse Pulsed dye laser (PDL) ,( pulse duration 1.5 and fluence 11) , on the whole port wine stain (PWS), after 20 minutes in months 0,1&2.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi dermatology hospital
Full name of responsible person
Dr. Amir housing ehsani
Street address
Razi skin hospital, Razi Ave, Vahdate eslami Ave, Hafiz St
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 5561 8989
Email
Ehsanih@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali sahraeian
Street address
Qods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
research@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
Zahra Razavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Razi skin hospital, Razi Ave, Vahdate eslami Ave, Hafiz St, Tehran city
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 5561 8989
Email
Razavi_z@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Razavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Razi skin hospital, Razi Ave, Vahdate eslami Ave, Hafiz St, Tehran City
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 5561 8989
Email
Razavi_z@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Razavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Razi skin hospital, Razi Ave, Vahdate eslami Ave, Hafiz St, Tehran city
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 5561 8989
Email
Razavi_z@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
Zahra Razavi
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.