| 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
|
|
|
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
|
|
|
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. |