Comparison of the efficacy and safety of Low-Fluence Q-Switched 1,064 nm Nd:YAG Laser and Low-Fluence CO2 Fractional Laser for treatment of melasma in patients referred to Shohada-e Tajrish hospital during 2012 :A Randomized Controlled Split-Face Study
Background: Melasma treatment remains challenging despite various laser systems available, because of potential side-effects and high recurrence rates. Aim: to Compare the efficacy and safety of Low-Fluence Q-Switched 1,064 nm Nd:YAG Laser and Low-Fluence CO2 Fractional Laser in the treatment of melasma. Method: 50 patients will be treated with Low-Fluence Q-Switched 1,064 nm Nd:YAG Laser on one side of the face and Low-Fluence CO2 Fractional Laser on the other side. Each patient will undergo laser therapy for 5 sessions every two week. The outcome will be evaluated periodically each session using the Melasma Area and Severity Index score and Melanin Index score. Follow up will be taken until 2 months after last session. Results will be analyzed and reported in the tables and diagrams.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201318146N2
Registration date:2012-08-27, 1391/06/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-08-27, 1391/06/06
Registrant information
Name
Mohammadreza Razaghi
Name of organization / entity
Laser application in medical sciences research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8021
Email address
laser.cntr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
laser application in medical science research center
Expected recruitment start date
2012-08-12, 1391/05/22
Expected recruitment end date
2013-08-13, 1392/05/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy and safety of Low-Fluence Q-Switched 1,064 nm Nd:YAG Laser and Low-Fluence CO2 Fractional Laser for treatment of melasma in patients referred to Shohada-e Tajrish hospital during 2012 :A Randomized Controlled Split-Face Study
Public title
Comparison of the efficacy and safety of two different lasers in the treatment of melasma
Purpose
Treatment
Inclusion/Exclusion criteria
All patients suffering from melasma that referred for treatment in during 2012 to the shohada-e tajrish treatment center form the study population.
Study inclusion criteria:
-Age between 18 to 85 years old
- Fitzpatrick skin type I-V
- symmetric distribution of melasma the in both sides of patient's face
study exclusion criteria:
-usage of pigment reducing topical treatments 2 weeks prior to the study
-usage of peeling agents 2 weeks prior to the study
-laser therapy for melasma 1 month prior to the study
-a history of poor wound healing, or abnormal scarring
-pregnancy or breast feeding
-history of keloid
-high exposure to sunlight or UV light 1 month prior to the study
-concurrent active herpes simplex lesion of the skin
-suspected hypersensitivity to lidocaine
-bleeding disorders
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti university of medical sciences
Street address
Daneshjo Blvd, Velenjak, Tehran, Iran
City
tehran
Postal code
Approval date
2012-06-10, 1391/03/21
Ethics committee reference number
119
Health conditions studied
1
Description of health condition studied
melasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma
Primary outcomes
1
Description
Melanin Index
Timepoint
After laser therapy
Method of measurement
Multi Probe adaptor
Secondary outcomes
empty
Intervention groups
1
Description
Each side of face is being numbed by cream lidocain 30 minutes before starting the procedure. In one side of the face, Q-Switched ND:YAG 1,064 laser with 1.5-2 j/cm2 fluence and 7 mili meter spot size is being used.
Category
Treatment - Other
2
Description
In the other side, the Low-Power Fractional CO2 laser with 1 j enery and 0.7 density is being used.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Laser application in medical sciences research center
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saadi Banar
Street address
Daneshjoo Blvd, Velenjak St, Tehran, Iran
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 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
Laser aplication in medical sciences research center
Full name of responsible person
Niloofar Jalali
Position
MD
Other areas of specialty/work
Street address
Shohada Tajrish medical center, Tajrish Sq
City
Tehran
Postal code
Phone
+98 21 2274 9221
Fax
Email
niloofar.jalaly@yahoo.fr
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Laser aplication in medical sciences research center
Full name of responsible person
Behrooz Barikbin
Position
Dermatologist
Other areas of specialty/work
Street address
Shohada Tajrish Medical center, Tajrish Sq
City
Tehran
Postal code
Phone
+98 21 2274 9221
Fax
Email
bbarikbin@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Laser aplication in medical sciences research center
Full name of responsible person
Niloofar Jalali
Position
MD
Other areas of specialty/work
Street address
Shohada Tajrish medical center, Tajrish Sq
City
Tehran
Postal code
Phone
Fax
Email
niloofar.jalaly@yahoo.fr
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)