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CTRI Number  CTRI/2025/08/093313 [Registered on: 20/08/2025] Trial Registered Prospectively
Last Modified On: 07/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [Topical Cream and Intralesional Injections under local anaesthesia ]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effectiveness of intralesional tranexamic acid in patients of melasma  
Scientific Title of Study   A COMPARATIVE STUDY BETWEEN INTRALESIONAL TRANEXAMIC ACID AND MODIFIED KLIGMAN’S REGIMEN IN THE TREATMENT OF MELASMA PATIENTS FROM EASTERN INDIA  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meenakshi Khemka  
Designation  Post graduate resident 
Affiliation  Institute of Post Graduate Medical Education and Research and SSKM Hospital Kolkata  
Address  Dermatology Department, IPGMER and SSKM Hospital, 244 AJC Bose Road
244 AJC Bose Road Kolkata 700020
Kolkata
WEST BENGAL
700020
India 
Phone  7980224023  
Fax    
Email  drmeenakshikhemka@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Kakali Mridha 
Designation  Head of the Department Dermatology  
Affiliation  Institute of Post Graduate Medical Education and Research and SSKM Hospital Kolkata  
Address  Dermatology Department, IPGMER and SSKM Hospital, 244 AJC Bose Road
244 AJC Bose Road Kolkata 700020
Kolkata
WEST BENGAL
700020
India 
Phone  7044745090  
Fax    
Email  kakali_mridha@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Meenakshi Khemka  
Designation  Post graduate resident 
Affiliation  Institute of Post Graduate Medical Education and Research and SSKM Hospital Kolkata  
Address  Dermatology Department, IPGMER and SSKM Hospital, 244 AJC Bose Road
244 AJC Bose Road Kolkata 700020
Kolkata
WEST BENGAL
700020
India 
Phone  7980224023  
Fax    
Email  drmeenakshikhemka@gmail.com  
 
Source of Monetary or Material Support  
Institute of Post Graduate Medical Education and Research and SSKM Hospital Kolkata  
 
Primary Sponsor  
Name  Institute of Post Graduate Medical Education and Research and SSKM Hospital Kolkata  
Address  244 AJC Bose Road Kolkata 700020 
Type of Sponsor  Government medical college 
 
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 
Meenakshi Khemka   IPGMER and SSKM Hospital Kolkata   Room number 1 Dermatology Department 244 AJC Bose Road Kolkata 700020
Kolkata
WEST BENGAL 
7980224023

drmeenakshikhemka@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGMER Research Oversight Committee   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  Intralesional Tranexamic acid injection at 4mg per ml strength   Patients with Melasma attending Dermatology OPD of IPGMER Kolkata during the study period meeting the criteria will be identified Written informed consent taken from the patients Data collected regarding medical and personal history demographics Dermoscopy Woods Lamp examination with assessment of the lesion done by modified MASI Score on first visit Digital photographs taken of the lesion Appropriate laboratory investigations especially Coagulation Profile done if indicated before starting treatment Patients will be randomly allocated into two groups using a computer generated random number table One group shall receive Intralesional Tranexamic Acid injections at 4mg per ml strength every 2 weeks up to 8 weeks and the other group shall apply Modified Kligmans Regimen once daily for 4 weeks then on alternate days for the next 4 weeks total duration 8 weeks Both the groups shall apply a broad spectrum sunscreen up to 12 weeks and evaluated Both groups of patients are assessed every 2 weeks with calculation of the MASI score, PGA Score and PtGA Score every 4 weeks and photographs taken fortnightly 
Comparator Agent  Modified Kligmans Regimen containing fluocinolone acetonide 0.01 percent with hydroquinone 4 percent and tretinoin 0.05 percent cream  Patients with Melasma attending Dermatology OPD of IPGMER Kolkata during the study period meeting the criteria will be identified Written informed consent taken from the patients Data collected regarding medical and personal history demographics Dermoscopy Woods Lamp examination with assessment of the lesion done by modified MASI Score on first visit Digital photographs taken of the lesion Appropriate laboratory investigations especially Coagulation Profile done if indicated before starting treatment Patients will be randomly allocated into two groups using a computer generated random number table One group shall receive Intralesional Tranexamic Acid injections at 4mg per ml strength every 2 weeks up to 8 weeks and the other group shall apply Modified Kligmans Regimen once daily for 4 weeks then on alternate days for the next 4 weeks total duration 8 weeks Both the groups shall apply a broad spectrum sunscreen up to 12 weeks and evaluated Both groups of patients are assessed every 2 weeks with calculation of the MASI score, PGA Score and PtGA Score every 4 weeks and photographs taken fortnightly 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patients attending the Dermatology OPD of IPGMER during the study period ages 18 to 60 years with bilaterally symmetrical or asymmetrical distribution of Melasma were included in the study with informed consent 
 
ExclusionCriteria 
Details  Pregnant or lactating females or patients on hormone replacement therapy or oral contraceptive pills or bleeding disorders or concomitant use of anticoagulants and any known drug allergy and or hypersensitivity especially to TA or patients of topical steroid dependent facies or unwillingly patients or patients with high treatment expectations or associated medical illness or history of any other depigmenting treatment in the past 1 month were excluded from the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Both groups of patients are assessed every 2 weeks with calculation of the MASI score up to 12 weeks
Modified MASI Score by Amer A et al
It is calculated using
A Area of involvement
D Darkness
Modified Melasma Area Severity Index Scale
Along with forehead f right malar region rm left malar region lm and chin c corresponding to 30 percent 30 percent 30 percent and 10 percent of the total face, respectively. The total score range is 0 to 24
0.3AfD plus 0.3AlmDlm plus 0.3ArmDrm plus 0.1AcDc 
Both groups of patients are assessed every 2 weeks with calculation of the MASI score up to 12 weeks
Modified MASI Score by Amer A et al
It is calculated using
A Area of involvement
D Darkness
Modified Melasma Area Severity Index Scale
Along with forehead f right malar region rm left malar region lm and chin c corresponding to 30 percent 30 percent 30 percent and 10 percent of the total face, respectively. The total score range is 0 to 24
0.3AfD plus 0.3AlmDlm plus 0.3ArmDrm plus 0.1AcDc 
 
Secondary Outcome  
Outcome  TimePoints 
PGA Score and PtGA Score every 4 weeks and photographs taken fortnightly up to 12 weeks
PHYSICIANS GLOBAL ASSESMENT SCALE PGA
CLEAR 90 to 100 percent
ALMOST CLEAR 75 to 90 percent
MARKED IMPROVEMENT 50 75 percent
MODERATE IMPROVEMENT 25 to 50 percent
SLIGHT IMPROVEMENT 1 to 25 percent
NO IMPROVEMENT 0
WORSE NEGATIVE

PATIENTS GLOBAL ASSESMENT SCALE PtGA
COMPLETELY CLEAR
NEARLY CLEAR
SIGNIFICANT HYPERPIGMENTATION
 
PGA Score and PtGA Score every 4 weeks and photographs taken fortnightly up to 12 weeks  
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   08/09/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Melasma is a common acquired disorder characterised by symmetric hyperpigmented patches with an irregular outline occurring most commonly on the face Although the exact pathogenesis is unknown melasma is thought to be caused by hyperfunction of the melanocytes in the skin following UV exposure leading to increased amounts of melanin Additionally hyperestrogenic states oral contraceptive pills medications like phenytoin phototoxic drugsnthyroid disease have a role in the pathogenesis of melasma It commonly involves the centrofacial region forehead cheeks nose upper lip sparing the philtrum and nasolabial folds chin malar region less commonly the mandibular region Based upon its location of the pigment it can be classified into epidermal dermal mixed or indeterminate Theoretically on Woods Lamp examination epidermal type enhances whereas dermal melanin becomes less obvious but this does not correlate on histopathology On dermoscopy melasma appears as light to dark brown globules with perifollicular sparing and the pigmentation pattern is reticular or pseudoreticular with diffuse dark brown to grey pigmentation involving the follicular openings 


As per Khuraiya et al  melasma has been treated with various treatment modalities most importantly sunscreen triple combination creams azelaic acid ascorbic acid kojic acid and arbutus chemical peels lasers but none might prove fully effective

Tranexamic Acid is a plasmin inhibitor and an antifibrinolytic which has potential as an emerging treatment modality for Melasma It has some anti inflammatory and hypopigmentary properties when used either systemically or topically TA inhibits plasminogen activator which helps in plasminogen to plasmin conversion It inhibits melanin synthesis by interfering with melanocyte keratinocyte interaction by inhibiting the plasmin system

According to Sarkar et al The use of tranexamic acid in melasma was an accidental discovery by Nijo et al in 1979 in a patient with urticaria Further the identification of the vascular component in melasma pathogenesis led to its rapid and widespread usage

Although oral Tranexamic Acid has been proven to be an effective treatment strategy in many studies evidence is required in the field of usage of intralesional TA in the treatment of Melasma


 
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