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comparison of fractional CO2 laser versus pulsed dye laser in the treatment of hypertrophic scars

Protocol summary

Summary
(1) Objectives: The aim of this study was to compare CO2 Fractional Laser and pulsed dye laser (PDL) methods in the treatment of hypertrophic scar. (2) Design: This is a double-blind clinical trial. (3) Procedure: Statistical population included patients visiting the skin clinic and clinically diagnosed with hypertrophic scar. (4) Inclusion and exclusion criteria: Patients with hypertrophic scar who were not undergoing any other treatment at the same time, and had no history of taking isotretinoin and pregnancy in the past six months were included in the study. (5) Interventions: The scars were split into two halves. Then, one half of each scar was randomly selected for laser therapy with CO2 fractional laser (CO2FL), and the second half received pulsed dye laser therapy (PDL). The therapeutic sessions were held every 4 weeks. (6) The main outcome variables: Improvement of scars was studied using three different evaluation methods. First, the degrees of pigmentation, flexibility, height, and vascularity of lesions were measured based on the Vancouver scar scale before the treatment and at each visit up to 4 sessions. Second, the treatment results were assessed by comparing clinical photographs before and after the treatment, using a 4-point grading scale. Third, patients were asked to rate their personal satisfaction of the treatment on a 4-point grading scale at the end of each session. Finally, the effects of these two laser therapies were compared, using the aforementioned scales.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016022326730N1
Registration date: 2016-04-08, 1395/01/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-08, 1395/01/20
Registrant information
Name
Samira Mehramiri
Name of organization / entity
Ahvaz Jundishapur University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 61 3292 1837
Email address
mehramiri.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
The cost of the project will be provided by private
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
comparison of fractional CO2 laser versus pulsed dye laser in the treatment of hypertrophic scars
Public title
comparison of fractional CO2 laser versus pulsed dye laser in the treatment of hypertrophic scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with hypertrophic scars Exclusion criteria: Receiving any topical injection or systemic treatment for lesion concurrent with study; Taking isotretinoin within last 6 months; Patients with photosensitivity ; Pregnancy.
Age
No age limit
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 35
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double 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 the Ahvaz Jundishapur University of Medical Scienses
Street address
Ethics Committee of the Ahvaz Jundishapur University of Medical Sciensees, University town, Golestan, Ahvaz, Khoozestan
City
Ahvaz
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.AJUMS.REC.1394.414

Health conditions studied

1

Description of health condition studied
hypertrophic scar
ICD-10 code
L91.0
ICD-10 code description
hypertrophic scar

Primary outcomes

1

Description
Hypertrophic scar improvement
Timepoint
Before intervention, Before each session of intervention,1 month after the last session
Method of measurement
Vancouver Scar Scale, Physician evaluation form, Patient satisfaction form

Secondary outcomes

1

Description
Pigmentary chanege in place
Timepoint
Before each session of intervention,1 month after the last session
Method of measurement
Observation

Intervention groups

1

Description
Intervention2: Fractional CO2 Laser 50 mj every 4 weeks for 4 sessions
Category
Treatment - Devices

2

Description
Intervention 1: PDL 585 nm laser every 4 weeks for 4 sessions
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Doctor Radmanesh Skin care Clinick
Full name of responsible person
Samira Mehramiri
Street address
Four East Streat, Kianpars, Ahvaz, Khoozestan
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Research Center, Ahvaz Jundishapur University of Medical Science, University town, Golestan, Ahvaz, Khoozestan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Scienses
Full name of responsible person
Seyed Mohamad Radmanesh
Position
Assistant Professor
Other areas of specialty/work
Street address
Dermatology Department, Emam Khomeini Hospital, Azadegan Street, Ahvaz, Khoozestan
City
Ahvaz
Postal code
Phone
+98 61 3292 1837
Fax
Email
radmanesh-m@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Scienses
Full name of responsible person
Seyed Mohammad Radmanesh
Position
Assistant Professor of Dermatology
Other areas of specialty/work
Street address
Dermatology Department, Emam Khomeini Hospital, Azadegan Street, Ahvaz, Khoozestan
City
Ahvaz
Postal code
Phone
+98 61 3292 1837
Fax
Email
radmanesh-m@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Scienses
Full name of responsible person
Samira Mehramiri
Position
Assistant of Dermatology
Other areas of specialty/work
Street address
Dermatology Department, Emam Khomeini Hospital, Azadegan Street, Department of Dermatologyr
City
Ahvaz
Postal code
Phone
+98 61 3292 1837
Fax
+98 61 3292 1837
Email
samira.mehramiri@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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