Comparison of therapeutic effects of Pulsed Dye Laser(PDL) and CO2 + PDL in treatment of Port Wine Stain
Design
Non randomized clinical trial with control group and blinded outcome assessment with sample size of 15 persons
Settings and conduct
This is a clinical trial on patients with port wine stain in Dr Radmanesh dermatology clinic in Ahvaz
Participants/Inclusion and exclusion criteria
Patients with port wine stain who are above 10 years old; aren’t pregnant and don’t lactate; negative history of hypertrophic scar and keloid and don’t have active infection or acne
Intervention groups
Intervention group is inferior part of lesions which is treated with CO2 + Pulsed Dye Lasers and control group is superior part of lesions which is treated only with Pulsed Dye laser
Main outcome variables
Clearance of port wine stain lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180402039169N1
Registration date:2018-04-20, 1397/01/31
Registration timing:retrospective
Last update:2018-04-20, 1397/01/31
Update count:0
Registration date
2018-04-20, 1397/01/31
Registrant information
Name
younes joonaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 1337 5786
Email address
joonaki.y@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Therapeutic Effects of Pulsed Dye Laser and Pulsed Dye+CO2 Lasers on Treatment of Port Wine Stain
Public title
Effect of Pulsed Dye + CO2 Lasers in treatment of Port Wine Stain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with Port Wine Stain
Patients above 10 years old
Exclusion criteria:
Female patients with pregnancy and lactation
Patients with history of hypertrophic scar and keloid
active infection and acne in treatment areas
Age
From 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Only the persons who measure the outcome are blinded, they don’t know which part of lesions are treated with both CO2 + Pulsed Dye lasers and which part is treated only with Pulsed Dye laser
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Ground floor, chancellor of Research, Ahvaz Jundishapur University of Medical Sciences, Daneshgahi town, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794 – 61357
Approval date
2018-01-23, 1396/11/03
Ethics committee reference number
IR.AJUMS.REC.1396.904
Health conditions studied
1
Description of health condition studied
Port Wine Stain
ICD-10 code
Q82.5
ICD-10 code description
Congenital non-neoplastic nevus
Primary outcomes
1
Description
Treatment of Port Wine Stain lesions according to clearance score
Timepoint
Six months after treatment
Method of measurement
Clearance score according to percent of clearance of lesions
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: we treat inferior part of lesions with CO2+Pulsed Dye Lasers
Category
Treatment - Devices
2
Description
Control group: we treat superior part of lesions with only Pulsed Dye Laser
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Doctor Radmanesh dermatologic clinic
Full name of responsible person
Younes Joonaki
Street address
4th east street, Kianpars Ave
City
Ahvaz
Province
Khouzestan
Postal code
615867916
Phone
+98 61 3392 1580
Email
younesmbc2@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ground floor, vice chancellor of Research, Ahvaz Jundishapur University of Medical Sciences, Daneshgahi town, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
Research@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Younes Joonaki
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
17th east street, Kianpars Ave, Ariana complex
City
Ahvaz
Province
Khouzestan
Postal code
613699410
Phone
+98 613375786
Email
younesmbc2@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Younes Joonaki
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
17th east street, Kianpars Ave, Ariana complex
City
Ahvaz
Province
Khouzestan
Postal code
613699410
Phone
+98 613375786
Email
younesmbc2@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Younes Joonaki
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
17th east street, Kianpars Ave, Ariana complex
City
Ahvaz
Province
Khouzestan
Postal code
613699410
Phone
+98 613375786
Email
younesmbc2@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available