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CTRI Number  CTRI/2024/01/061416 [Registered on: 12/01/2024] Trial Registered Prospectively
Last Modified On: 27/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to assess the effect of Tranexamic acid injection and Tranexamic acid cream in patients with melasma 
Scientific Title of Study   COMPARATIVE STUDY OF TRANEXAMIC ACID MESOTHERAPY VERSUS TOPICAL TRANEXAMIC ACID IN PATIENTS WITH MELASMA  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yash Kashikar 
Designation  Junior Resident 
Affiliation  Datta Meghe Institute of Higher Education & Research Sawangi 
Address  118 Department of Dermatology Venereology and Leprosy AVBRH Sawangi Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  8379079326  
Fax    
Email  yash.kashikar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhushan Madke 
Designation  HOD 
Affiliation  Datta Meghe Institute of Higher Education & Research Sawangi 
Address  118 Department of Dermatology Venereology and Leprosy AVBRH Sawangi Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  7499315645  
Fax    
Email  drbhushan81@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Yash Kashikar 
Designation  Junior Resident 
Affiliation  Datta Meghe Institute of Higher Education & Research Sawangi 
Address  118 Department of Dermatology Venereology and Leprosy AVBRH Sawangi Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  8379079326  
Fax    
Email  yash.kashikar@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research Wardha 
 
Primary Sponsor  
Name  Dr Yash Kashikar 
Address  104 Ward No 15 Maganwadi Road Ramnagar Wardha 
Type of Sponsor  Other [Principle investigator] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yash Kashikar  ACHARYA VINOBA BHAVE RURAL HOSPITAL  SAWANGI MEGHE
Wardha
MAHARASHTRA 
8379079326

yash.kashikar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L814||Other melanin hyperpigmentation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Topical Tranexamic acid  Tranexamic acid gel (3%) will be given to the patients. Patients will be advised to apply a broad spectrum sunscreen with a sun protection factor of 30 or higher in the morning, and reapplication of the sunscreen every 3 hours.Patients will be followed up at 4 weeks and 8 weeks. 
Intervention  Trannexamic Acid Mesotherapy  Mesotherapy will be done using MESO-ICE device and injectable Tranexamic acid (500mg) will be used as the medium for mesotherapy. Patients will be advised to apply a broad spectrum sunscreen with a sun protection factor of 30 or higher in the morning, and reapplication of the sunscreen every 3 hours.Patients will be followed up 4 weeks and 8 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  A clinical diagnosis of melasma between the ages of 18 to 65 years


 
 
ExclusionCriteria 
Details  Patients suffering from significant systemic illness and on certain drugs such as anticoagulants, oral contraceptive pills, hormone replacement therapy, NSAIDs, antiepileptic medications, isotretinoin, or any other phototoxic medication, with known hypersensitivity to Tranexamic acid

Pre-existing facial dermatoses

Past history of thrombotic disease such as deep vein thrombosis

Pregnancy and lactation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction of Melasma Assesment & Severity Index score (MASI) by Tranexamic acid mesotherapy in comparison to topical application  Baseline, 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction of MASI score by Tranexamic acid mesotherapy in comparison to topical application   8 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

In recent years, off-label Tranexamic acid (TA) has emerged as a potential treatment for melasma. Although the mechanism of action remains unclear, it is thought that TA may inhibit melanin synthesis by blocking the interaction between melanocytes and keratinocytes. TA may also reverse the abnormal dermal changes associated with melasma, such as the aforementioned increased vasculature. While different forms of TA (i.e. oral, topical, and localized microinjections) have shown promising results.

However, till date, there is no consensus on the optimum route, dose, and timing of the treatment with TA in melasma. It has been tried both orally and topically. When used along with micro-needling, the frequency of the treatment depends on the size of the derma-roller used that is, the needle size. Hence the present study is needed to comparatively evaluate the effect of topical versus mesotherapy using Tranexamic acid. Moreover, the novel mesotherapy device used in the study which uses cryo electroporation technology without using needles could provide a new approach to conventional microneedling.

 
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