Comparison of the efficacy and safety of Q-Switch 1,064 nm Nd:YAG Laser with and without carbon photo enhancer lotion on reducing skin pigmentation in patients with Melasma referred to Skin and Stem cell research center of Tehran University of Medical Sciences
High prevalence of melasma and its great psychological impact necessitates an efficacious, economic and safe therapeutic option. The aim of this study is to evaluate the efficacy and safety of topical carbon application with Q-switched neodymium-doped yttrium aluminium garnet (Nd:YAG) 1064 nm laser in the treatment of melasma. Methods: in this prospective trial, symmetric melasma lesions of 43 patients age between 18 and 85 years old are randomly divided into two parts to receive Nd:YAG laser with exogenous topical carbon application on a half while the other half receive Nd:YAG laser alone. The Nd:YAG laser will be used with the following parameters: fluence= 1.5-2 Joules per centimeter, spot size= 7 Millimeters. The treatment protocol consists of 6 sessions, 3 sessions with one-week intervals and 3 other sessions with 2-week intervals. The main outcomes will be assessed by colorimeter, Mexameter, and calculating the modified Melasma Area and Severity Index. The side effects and the degree of patients’ satisfaction will also be recorded. Statistical analysis will be performed using statistical software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308181159N9
Registration date:2013-10-19, 1392/07/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-10-19, 1392/07/27
Registrant information
Name
Mohamad Ali Nilforoushzadeh
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 5158
Email address
sdlrc@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy and safety of Q-Switch 1,064 nm Nd:YAG Laser with and without carbon photo enhancer lotion on reducing skin pigmentation in patients with Melasma referred to Skin and Stem cell research center of Tehran University of Medical Sciences
Public title
Comparison of efficacy of laser Q-Switch 1,064 nm Nd: YAG with two different methods in the treatment of Malasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18 and 85 years old; Fitzpatrick skin type I-V; symmetric distribution of melasma the in both sides of patient's face;
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, and solarium usage one month prior to the treatment.
Age
From 18 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
43
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
According to this topic that patients with symmetric damages on the face will be entered into the study, right or left part of the face will randomly receive carbon solution through laser.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Enghelab Street, Tehran, Iran
City
Tehran
Postal code
Approval date
2013-07-21, 1392/04/30
Ethics committee reference number
92-01-150-22588-89288
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
Before laser therapy
Method of measurement
Multi Probe adaptor
Secondary outcomes
empty
Intervention groups
1
Description
Laser group with topical carbon: one half of face (A side) receives 3 sessions of Nd:YAG laser (fluence= 1.5-2 Joules per centimeter, spot size=7 Millimeters) with topical carbon at 1-week intervals followed by 3 same sessions at 2-week intervals.
Category
Other
2
Description
Laser group without topical carbon: In the other side (B group), the same laser therapy will be administered at one half of face receives 3 sessions of Nd:YAG laser (fluence=1.5-2 Joules per centimeter, spot size=7 Millimeters) without topical carbon at 1-week intervals followed by 3 same sessions at 2-week intervals.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Elham Rahimi
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Masoud Younesian
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences, Enghelab Street, 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
Vice Chancellor for Research, Tehran 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 and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Elham Rahimi
Position
General Practitioner
Other areas of specialty/work
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2223 9387
Fax
Email
elhamrahimimd@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Position
Dermatologist
Other areas of specialty/work
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2223 9387
Fax
Email
sdlrc@mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)