Comparison of the efficacy of ablative fractional CO2 laser combined with punch elevation vs ablative fractional CO2 laser alone in treatment of depressed acne scar.
Objectives: To compare the efficacy of Ablative Fractional CO2 Laser plus Punch elevation, with Ablative Fractional CO2 Laser alone for treatment of depressed acne scars.
Design: Randomized, single blind, clinical trial.
Setting and Conduct: In a dermatology clinic setting, 24 hours before first episode of laser therapy, eligible patients receive punch elevation on one side of the face chosen randomly. After 24 hours, both sides receive laser therapy with Fractional CO2 laser. Additionally, patients receive a repeat laser therapy session after one months. Outcome measures will be assessed by the use of serial photography at baseline, one, and four months after the first laser therapy session by two independent dermatologists blinded to the randomization.
Major Inclusion and Exclusion criteria: Inclusion criteria: Age ≥ 18 years; patient suffering from polymorphic and mixed acne scars; Fitzpatrick skin types 2 to4; informed consent for participation
Exclusion Criteria: Presence of hypertrophic or Keloid scars; patient not returning for follow up visits; patient discontinuing intervention; suspect pregnancy.
Intervention: One arm receives Fractional CO2 Laser plus punch elevation (with punch device gauges 1.5 to3.0) and the other receives Fractional CO2 Laser alone.
Main Outcome Measures: Improvement in acne scar assessed by two independent dermatologists blinded to the randomization process and by means of serial photography.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014080218647N1
Registration date:2014-09-29, 1393/07/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-29, 1393/07/07
Registrant information
Name
Saeid Nouraei
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3628 9559
Email address
saeidnouraei@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research of Isfahan University of Medical Sciences.
Expected recruitment start date
2014-05-05, 1393/02/15
Expected recruitment end date
2014-11-06, 1393/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of ablative fractional CO2 laser combined with punch elevation vs ablative fractional CO2 laser alone in treatment of depressed acne scar.
Public title
Efficacy of Fractional CO2 laser with or without punch elevation for treatment of depressed acne scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age ≥18 years; patient suffering from polymorphic and mixed acne scars; Fitzpatrick skin types2 to4; informed consent for participation.
Exclusion Criteria: Presence of hypertrophic or Keloid scars; patient not returning for follow up visits; patient discontinuing intervention; suspect pregnancy.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The side of the face to receive punch elevation was determined by a random process
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Deputy of research of Isfahan University of Medical Sciences, Hezar jerib Avenue, Isfahan.
City
Isfahan
Postal code
Approval date
2013-10-30, 1392/08/08
Ethics committee reference number
392491
Health conditions studied
1
Description of health condition studied
acne scar
ICD-10 code
l90.5
ICD-10 code description
Scar conditions and fibrosis of skin
Primary outcomes
1
Description
Atrophic scar of acne
Timepoint
One and four months after the first laser therapy session
Method of measurement
by two independent dermatologists blinded to the randomization
Secondary outcomes
1
Description
Edema; Erythema; Pruritis; Hypo and Hyper pigmentation
Timepoint
After three days, one week, one month and four months the first laser therapy session
Method of measurement
Patient self administered checklist of overall satisfaction
2
Description
Clinical improvement of atrophic scar
Timepoint
One and four months after the first laser therapy session
Method of measurement
Patient self administered checklist of overall satisfaction
3
Description
Patients satisfaction
Timepoint
One and four months after the first laser therapy session
Method of measurement
Visual Analog Score
Intervention groups
1
Description
In one side of the face, 24 hours before the first session of laser treatment, punch elevation is done, followed by a session of Fractional CO2 ablative (Q ray, Diosis Inc, Seoul, Korea) with pulse energy: 25 mj per fixed150 μm diameter microbeam, density400 MTZ/cm2.
Category
Treatment - Devices
2
Description
On the other side of the face, without punch elevation (control group) a session of Fractional CO2 ablative (Q ray, Diosis Inc, Seoul, Korea) with pulse energy: 25 mj per fixed150 μm diameter microbeam, density400 MTZ/cm2 is administered.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
AL Zahra Hospital and Sedigheh tahere center
Full name of responsible person
Dr Saeid Nouraei
Street address
Department of Dermatology, Al Zahra Hospital, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Dr Ebrahim Esfandiari
Street address
Deputy of Research of Isfahan University of Medical Sciences, Hezar Jerib Avenue, Isfahan.
City
Isfahan
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 of Isfahan 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
Skin disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Ira
Full name of responsible person
Dr Saeid Nouraei
Position
Assistant of dermatology
Other areas of specialty/work
Street address
Department of dermatology, Al Zahra Hospital , Soffeh Blvd
City
Isfahan
Postal code
8173955765
Phone
+98 31 3628 9194
Fax
+98 31 3628 9194
Email
saeidnouraei@resident.mui.ac.ir
Web page address
www.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Ira
Full name of responsible person
Dr Gita Fagihi
Position
Professor
Other areas of specialty/work
Street address
Department of Dermatology, Al Zahra Hospital, Soffeh Blvd, Isfahan University of Medical Sciences .
City
Isfahan
Postal code
Phone
+98 31 3663 3061
Fax
+98 31 3663 3061
Email
g_fagihi@med.mui.ac.ir
Web page address
www.med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Skin disease and Leishmaniasis Research Center, Isfahan University of Medical Sciences, Isfahan, Ira
Full name of responsible person
Dr Saeid Nouraei
Position
Assistant of Dermatology
Other areas of specialty/work
Street address
Department of Dermatology, Al-Zahra Hospital, Soffeh Blvd, Isfahan University of Medical Sciences
City
Isfahan
Postal code
8173955765
Phone
+98 31 3628 9194
Fax
+98 31 3628 9194
Email
saeidnouraei@resident.mui.ac.ir
Web page address
www.med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)