The aim of this study is to compare the treatment of Nd-Yag fractional 1064 laser with tranexamic acid mesotherapy to Nd-Yag fractional 1064 laser therapy with oral tranexamic acid.
Design
In this study, 34patients were randomly divided into two equal groups A and B. In order to randomization, a box of 34pre-filled envelopes which containing A or B code is considered for each patient. Group A received Nd-YAG-Fractional 1064 lasers with tranexamic acid mesotherapy and in group B, the same laser with oral tranexamic acid(1 cap 250 mg every 8 hours for 3 months)was used. Laser therapy consists of 6 sessions at intervals every 2weeks. Finally, 40participants (20people in each group) were included in this study, which is a Phase 3 clinical trial, due to the possible withdrawal of the subjects from the study and follow-up.
Settings and conduct
this double-blind, researcher and analyzer, interventional study was conducted on patients with melasma referring to the Dermatology Clinic of Rasool-Akram hospital.
Participants/Inclusion and exclusion criteria
The inclusion criteria are women suffered melasma with aged 18-50 and I-IV Fitz Patrick skin type and without any diseases associated with tranexamic acid.
the exclusion criteria are the incidence of any side effects associated with treatment or the patient's reluctance to continue treatment.
Intervention groups
Nd-Yag-Fractional 1064 laser therapy with tranexamic acid microinjection was done for the first group and the second group treated with the same laser and oral tranexamic acid.
Main outcome variables
The degree of clarification and improvement of melasma lesions; satisfaction of patients; tolerability; complications of treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140624018210N9
Registration date:2019-04-13, 1398/01/24
Registration timing:registered_while_recruiting
Last update:2019-04-13, 1398/01/24
Update count:0
Registration date
2019-04-13, 1398/01/24
Registrant information
Name
Elham Behrangi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 2040
Email address
behrangi.e@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Nd-Yag fractional 1064 laser therapy with tranexamic acid mesotherapy efficacy versus Nd-Yag fractional 1064 laser therapy with oral tranexamic acid in patients suffering melasma.
Public title
Comparison of Nd-Yag fractional 1064 laser therapy with tranexamic acid mesotherapy efficacy versus Nd-Yag fractional 1064 laser therapy with oral tranexamic acid in patients suffering melasma.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients should have the classical clinical features of melasma.
skin type of patients should be I to IV.
patients age should be between 18 to 50.
Exclusion criteria:
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
20
although 34 participants were estimated for this study, we have considered 40 participants because of the probably missing data. then 20 patients suffered from melasma, were entered in each group.
Randomization (investigator's opinion)
Randomized
Randomization description
patients were entered into each treatment group by computerized random selection with 1:1 ratio. each patient will choose an envelope from a box filled with 60 closed envelope which contains A or B code. (A --> first method and B--> second method)
Blinding (investigator's opinion)
Double blinded
Blinding description
in this double-blind study, unlike the first researcher, second researcher, and analyzer just have access to A and B code. thus they do not know about the exact treatment.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran Univercity of Medical Sciences
Street address
Niyayesh Ave.,Sattar khan Blvd.
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2018-06-11, 1397/03/21
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9511166001
Health conditions studied
1
Description of health condition studied
melasma
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Brightening and improving the appearance of melasma by MASI score
Timepoint
Before the begin of the intervention and then 2, 4, 6, 8, 10, 12 weeks after the treatment in the studied groups
Method of measurement
The device used is Visioface, a scale used in study is melasma area severity index, and a questionnaire on the patient's healing process has also been used.
Secondary outcomes
1
Description
side effect of treatment , tolerability , satisfaction
Timepoint
2, 4, 6, 8, 10, 12, 16 weeks after each treatment stage