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CTRI Number  CTRI/2023/10/058614 [Registered on: 13/10/2023] Trial Registered Prospectively
Last Modified On: 28/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing efficacy of different preparations of Tranexamic Acid in the management of melasma 
Scientific Title of Study   A prospective, randomised study comparing the therapeutic efficacy and safety of topical, oral and localised intradermal microinjections of tranexamic acid in patients with facial melasma. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashutosh Trivedi 
Designation  Junior Resident 
Affiliation  Shri Bhausaheb Hire Government Medical College Dhule 
Address  Department of Dermatology, Venereology and Leprosy, OPD Number 18, Shri Bhausaheb Hire Government Medical College Chakkarbardi, Surat bypass, Dhule

Dhule
MAHARASHTRA
424001
India 
Phone  9920305434  
Fax    
Email  ashutoshtrivedi7196@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chetan Rajput 
Designation  Professor and Head of Department 
Affiliation  Shri Bhausaheb Hire Government Medical College Dhule 
Address  Department of Dermatology, Venereology and Leprosy, OPD Number 18, Shri Bhausaheb Hire Government Medical College Chakkarbardi, Surat bypass, Dhule


MAHARASHTRA
424001
India 
Phone  8888487808  
Fax    
Email  drchetanrajput@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Ashutosh Trivedi 
Designation  Junior Resident 
Affiliation  Shri Bhausaheb Hire Government Medical College Dhule 
Address  Department of Dermatology, Venereology and Leprosy, OPD Number 18, Shri Bhausaheb Hire Government Medical College Chakkarbardi, Surat bypass, Dhule


MAHARASHTRA
424001
India 
Phone  9920305434  
Fax    
Email  ashutoshtrivedi7196@gmail.com  
 
Source of Monetary or Material Support  
Shri Bhausaheb Hire Government Medical College Chakkarbardi, Surat bypass, Dhule - 424001  
 
Primary Sponsor  
Name  Ashutosh Trivedi 
Address  Shri Bhausaheb Hire Government Medical College Chakkarbardi, Surat bypass, Dhule - 424001  
Type of Sponsor  Other [Self] 
 
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 Ashutosh Trivedi  Shri Bhausaheb Hire Government Medical College  Department of Dermatology, Venereology and Leprosy, OPD Number 18, Shri Bhausaheb Hire Government Medical College Chakkarbardi, Surat bypass, Dhule - 424001
Dhule
MAHARASHTRA 		 9920305434

ashutoshtrivedi7196@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Shri Bhausaheb hire Government Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L811||Chloasma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intradermal Tranexamic Acid  Intradermal injection of tranexamic acid at 0,2,4,6,8,10 and 12 weeks 
Comparator Agent  Oral Tranexamic Acid  250mg Twice a day to be taken for 12 weeks. 
Comparator Agent  Topical Tranexamic Acid  Topical tranexamic acid twice daily local application over lesions for 12 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All adult patients diagnosed with facial melasma 
 
ExclusionCriteria 
Details  Children < 18 years of age, pregnant or nursing women or women planning pregnancy during the duration of trial.
Patients with Extra - facial melasma
Patient unwilling to give consent to be part of trial.
Current use of oral or injectable contraceptives, hormone replacement therapy, blood thinning medications, photosensitizing drugs or drugs known to cause hyperpigmentation of skin.
Current or previous use of any medical treatment (topical or oral) or cosmetic procedure (chemical peel, Laser, Dermabrasion) for melasma within 9 months of study enrollment.
History of thromboembolic disease such as deep vein thrombosis (DVT), >2 spontaneous abortions, pulmonary embolism or cerebral thrombosis, stroke or subarachnoid haemorrhage.
Family history of thromboembolic disease.
Smoking, tobacco use.
Hypersensitivity to tranexamic acid or sunscreen ingredients.
Abnormal bleeding profile (PT INR, Bleeding Time, Clotting Time). 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Compare efficacy of therapy with respect to decrease in size and hyperpigmentation of lesion  Calculation of modified Melasma Severity Index.
Assessment of clinical photographs by blinded physicians by percentage response scale.
Patient satisfaction measured according to 5 point Liker Scale.
Measured at baseline,4 weeks, 8 weeks, 12 weeks and 3 months post treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Analyze the safety and tolerability of different preparations of tranexamic acid with respect to adverse effects related to therapy  Compared during course of therapy, at end of therapy and end of post treatment follow up period. 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/12/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ashutoshtrived7196@gmail.com].

  6. For how long will this data be available start date provided 07-01-2026 and end date provided 11-01-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Melasma is an acquired facial hypermelanosis that presents as light to dark brown macules and patches most commonly seen over sun exposed areas of face and neck. The chronic recurring nature of the disease, incomplete understanding of disease pathogenesis and unstable patient response to treatment provide a unique challenge to the treating physician. The cosmetic disfigurement caused can be socially distressing affecting patient quality of life.
Various treatment options include topical and oral medicaltions, procedures, chemical peels, Lasers and combination therapy. Tranexamic Acid has emerged as an effective treatment option finding use in topical, oral and intradermal preparations.
This randomized, prospective study aims to compare efficacy and safety of topical, oral and intradermal Tranexaic acid in the treatment of facial melasma. Study will be conducted in a tertiary care set up. Patients enrolled will be divided into 3 groups. Group A will receive topical tranexamic acid. Group B will receive oral tranexamic acid and Group C will be treated using intradermal injections of tranexamic acid. Treatment duration is  months with a follow up period of 3 months.


 
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