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Efficacy and safety of fractional Co2 laser versus fractional Er:YAG in treatment of facial rhytides

Protocol summary

Summary
Study purpose: Efficacy and safety of fractional Co2 laser versus fractional Er:YAG in treatment of facial rhytides determination study design:randomized,double blined,parallel,phase1 clinical trial. Methodology: Target selection:Patients referring to Shohadaye Tajrish Educational Hospital a) Inclusion criteria:1)females between 35 and 60years of age 2)patients with mild to moderate facial rhytides at rest Exclusion criteria included: 1)males 2)females younger than 35 yerars old 3)pregnancy and lactatation 4)cosmetic procedures affecting the treatment area (e.g.,botulinum toxin, dermabrasion, chemical peeling, laser surgery, or face-lift) within the last 6months 5) oral isotretinoin within the last 6months 6) history of keloid formation Target sample size:40 b) Study interventions:Patients were randomly assigned to receive treatment on each side of face , one with a fractional CO2 and one with a fractional Er:YAG laser. c)Time of the intervention:3 treatment sessions with 1 month interval for each patient d)Study outcome:The evaluation both before each treatment session and 3months after the last one will be done with reviscometer and digital photography as well as assessment of side effects (eg.,pain,stinging,pruritis,redness,bulla,bleeding,crust formation,hypopigmentation,hyperpigmentation,scar,atrophy)will be performed .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014122820468N1
Registration date: 2015-03-26, 1394/01/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-03-26, 1394/01/06
Registrant information
Name
Reza Robati
Name of organization / entity
Skin Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 1507
Email address
rezarobati@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Dermatology Research Center of Shahid Beheshti University of Medical Science
Expected recruitment start date
2015-01-15, 1393/10/25
Expected recruitment end date
2015-07-21, 1394/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of fractional Co2 laser versus fractional Er:YAG in treatment of facial rhytides
Public title
Efficacy of laser in skin rejuvination
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:females between 35 and 60years of age ;patients with mild to moderate facial rhytides at rest Exclusion criteria :males;females younger than 35 yerars old;pregnancy and lactatation;cosmetic procedures affecting the treatment area (e.g.,botulinum toxin,dermabrasion, chemical peeling, laser surgery, or face-lift)within the last 6months;oral isotretinoin within the last 6months; history of keloid formation
Age
From 35 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
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
Skin Research Center,Shahid Beheshti University of Medical Science
Street address
The SBMU SRC (Skin Research Center),Shohada-E- Tajrish Educational Hospital,Qods Sq. ,Tehran, Iran
City
Tehran
Postal code
Approval date
2013-11-18, 1392/08/27
Ethics committee reference number
192/93

Health conditions studied

1

Description of health condition studied
Skin rejuvenation
ICD-10 code
L98.8
ICD-10 code description
Other specified disorders of skin and subcutaneous tissue

Primary outcomes

1

Description
skin elasticity
Timepoint
before treatment_before each session_3month after the last session
Method of measurement
resonance running time/reviscometer

2

Description
rhytides improvement
Timepoint
before treatment_before each session_3month after the last session
Method of measurement
improvment percentage_comparing digital photoghraphes by dermatologist

3

Description
Patient satisfaction
Timepoint
1month after session 1&2-three month after session3
Method of measurement
percentage- Patient satisfaction questionnaire

Secondary outcomes

1

Description
side effects(pain-burning and stinging-erythem-edema-bulla-bleeding-crust formation-hypopigmentation-hyperpigmentation-scar-atrophy)
Timepoint
one week after each treatment session
Method of measurement
patient evaluation with questionnaire-dermatologist evaluation

2

Description
side effects lasting
Timepoint
until one week after each treatment
Method of measurement
day

Intervention groups

1

Description
Topical anesthetic gel is applied to both sides of face and left for 30minutes. The patient's eyes are covered with a shield during the entire procedure. Patients are randomly assigned to receive treatment with a fractional Co2 Laser on one side of face ;which is focused to a spot size of approximately 120 micrometer in diameter ,the pulse duration of 10 milliseconds and pulse energy varies from 5 to 70mJ .Three treatment sessions with 1 month interval for each patient will be done.The evaluation before each treatment session and 3months after the last one will be done with the reviscometer and digital photography .
Category
Treatment - Other

2

Description
Topical anesthetic gel is applied to both sides of face and left for 30minutes. The patient's eyes are covered with a shield during the entire procedure. Patients are randomly assigned to receive treatment with a fractional Er-YAG Laser on one side of face ;which is focused to a spot size of approximately 250 micrometer in diameter ,the pulse duration of 400microseconds and total fluence of 60J/cm2 .Three treatment sessions with 1 month interval for each patient will be done.The evaluation both before each treatment session and 3months after the last one will be done with reviscometer and digital photography .
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada-E- Tajrish Educational Hospital
Full name of responsible person
Dr Reza Robati-Assistant Professor of Dermatology
Street address
The SBMU SRC (Skin Research Center),Shohada-E- Tajrish Educational Hospital,Qods Sq. ,Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Science-Skin Research Center
Full name of responsible person
Dr Parviz Toosi
Street address
Iran, Tehran, Velenjak St. , Shahid Chamran Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Science-Skin Research Center
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 Research Center
Full name of responsible person
Elmira Asadi
Position
Assistant Resident of Dermatology
Other areas of specialty/work
Street address
The SBMU SRC (Skin Research Center),Shohada-E- Tajrish Educational Hospital,Qods Sq. ,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2274 1507
Fax
Email
asadielmira8@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Skin Research Center
Full name of responsible person
Dr Reza Robati
Position
Assistant Professor of Dermatology
Other areas of specialty/work
Street address
The SBMU SRC (Skin Research Center),Shohada-E- Tajrish Educational Hospital,Qods Sq. ,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2274 1507
Fax
Email
rezarobati@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Skin Research Center
Full name of responsible person
Elmira Asadi
Position
Assistant Resident of Dermatology
Other areas of specialty/work
Street address
The SBMU SRC (Skin Research Center),Shohada-E- Tajrish Educational Hospital,Qods Sq. ,Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2274 1507
Fax
+98 21 2274 1507
Email
asadielmira8@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
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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