The purpose of the study is to determine if combination of microdermabrasion and Q-switched Nd:YAG laser, produced significant improvement of melasma when compared with Q-switched Nd:YAG laser alone.
Design
This is a non-blind randomized clinical trial with a split-face design and parallel groups with 30 subjects.outcome assessment is going to be done blindly.Randomization is by use of permuted block randomization.
Settings and conduct
Patients come to the Niyusha clinic every month and each session undergo microdermabrasion on half of their faces (that will be chosen randomly) and a laser beam therapy for both sides of their faces using 1064 nm Q-switch Nd-YAG laser.
Participants/Inclusion and exclusion criteria
Inclusion criteria is women and men older than 18 years with bilateral moderate or severe melasma. Exclusion criteria includes pregnancy , breast feeding ,use of any 4% hydroquinone formulation within 3 months of entry , history of chemical peels , microdermabrasion or facial laser treatment within 9 months of entry.
Intervention groups
This is going to be a split-face study and for each patient,one half of face will be test and the other half will be the control.The side allocated randomly to receive microdermabrasion prior to laser therapy , was treated with a total of 3 pass in each session at the following visits : baseline , month 1 , month 2 and month 3.The face was then rinsed with water and dried and immediately both sides of patient’s face was treated with Q-switched Nd:YAG laser (1064 nm ) with fluences of 2.5 -6.5 J/cm² with a 4 or 6 mm spot ,using only 2 laser passes to achieve complete coverage of the affected skin.
Main outcome variables
Melasma Area and Severity Index (MASI ) ;
Physician Global melasma improvement Assessment (PhGA) ;
Patient Global melasma improvement Assessment (PGA) ;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191228045917N2
Registration date:2020-09-20, 1399/06/30
Registration timing:prospective
Last update:2020-09-20, 1399/06/30
Update count:0
Registration date
2020-09-20, 1399/06/30
Registrant information
Name
Parvaneh Hatami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5560 9951
Email address
p-hatami@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-06, 1399/07/15
Expected recruitment end date
2021-01-04, 1399/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of combination of Q-switch Nd:YAG laser and microdermabrasion , with Q-switch Nd:YAG laser alone in treatment of melasma
Public title
laser and microdermabrasion in melasma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
women and men older than 18 years with bilateral moderate or severe melasma clinically diagnosed by a dermatologist
Exclusion criteria:
pregnancy
breast feeding
use of any 4% hydroquinone formulation within last 3 months
history of chemical peels
microdermabrasion or facial laser treatment within last 9 months
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
lesions in each side of individual's face are considered as one sample.
Randomization (investigator's opinion)
Randomized
Randomization description
For random allocation of two types of treatment (laser with or without microdermabrasion), at first, face of subject is divided to 2 parts (right and left),then we generate 30 (number of our subjects) random samples with block randomization with considering 2 treatments and 4,6 and 8 blocks .Finally , we consider one side of face (that is chosen randomly) constant and based on random sequence generated, allocate the treatment with laser and microdermabrasion to that side of face.It is obvious that the other side will undergo treatment with laser alone.
For generation of random sequence , we will use an online software with this address :
https://www.sealedenvelope.com/simple-randomiser/v1/lists
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is going to be done as a split-face study.So each patient will be its own control
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjanuniversity of medical sciences
Street address
Emam Ali Blv.Central building
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2016-03-13, 1394/12/23
Ethics committee reference number
IR.RUMS.REC.1394.279
Health conditions studied
1
Description of health condition studied
Melasma
ICD-10 code
L81.1
ICD-10 code description
Chloasma
Primary outcomes
1
Description
Melasma Area and Severity Index (MASI ) score ; Physician Global melasma improvement Assessment (PhGA) score ;Patient Global melasma improvement Assessment (PGA) score
Timepoint
baseline.12 week,16 week, 32 week
Method of measurement
Photographic evaluation by dermatologist- general assessment of the patient-asking from patients
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The side allocated to receive microdermabrasion prior to laser therapy , is treated with a total of 3 pass in each session at the following visits : baseline , month 1 , month 2 and month 3.After degreasing with alcohol and waiting for the skin to dry , 3 pass microdermabration is done using 6 mm head and 400 mmHg pressure to achieve mild erythema.After washing with water and drying, treatment with Q-switched Nd:YAG laser (1064 nm ) with fluences of 2.5 -6.5 J/cm² with a 4 or 6 mm spot ,using 2 laser passing will be done.
Category
Treatment - Other
2
Description
Control group:The other side of face is treated with Q-switched Nd:YAG laser (1064 ) with fluences of 2.5 -6.5 J/cm² with a 4 or 6 mm spot ,using 2 laser passing.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Niyusha clinic
Full name of responsible person
Dr Parvaneh Hatami
Street address
No 180,11th street, Gisha street,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1447683378
Phone
+98 21 8824 2020
Email
p_hatami2001@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran's national ellites foundation
Full name of responsible person
Dr Alireza Saeedi
Street address
No 209,Tahernia Av.Azadi St.Tehran,Iran
City
Teharn
Province
Tehran
Postal code
1457893111
Phone
+98 21 6347 8000
Email
p_hatami2001@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran's national ellites foundation
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvaneh Hatami
Position
researcher
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No 180,11th St.,Gisha St.
City
Tehran
Province
Tehran
Postal code
1447683378
Phone
+98 21 8824 2020
Email
p_hatami2001@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvaneh Hatami
Position
researcher
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No 180,11th St,Gisha St.
City
Tehran
Province
Tehran
Postal code
1447688378
Phone
+98 21 8824 2020
Email
p_hatami2001@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvaneh Hatami
Position
researcher
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No180.11th St.Gisha St.
City
Tehran
Province
Tehran
Postal code
1447688378
Phone
+98 21 8824 2020
Email
p_hatami2001@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All patient information can be shared without naming and identifying them
When the data will become available and for how long
Details of the data are immediately available after publishing the results
To whom data/document is available
All researchers and health professionals working in academic ,scientific and medical institutions.
Under which criteria data/document could be used
The data is only shared for person whose purpose is to improve the therapeutic course of Melasma