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CTRI Number  CTRI/2025/07/091564 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 23/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Comparing Inj tranexamic acid with PRP in patients with melasma to find out which one has better outcome. 
Scientific Title of Study   A comparative study to evaluate the efficacy of intralesional tranexamic acid versus intralesional platelet rich plasma in the treatment of 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  Ashrita Krishna 
Designation  Post graduate student 
Affiliation  Hassan Institute Of Medical Sciences 
Address  Department of Dermatology venereology and leprosy,1st floor,room no 14,Hassan institute of medical sciences campus, Hassan

Hassan
KARNATAKA
573201
India 
Phone  9632221374  
Fax    
Email  ashrita.kr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Suresh MR 
Designation  Associate Professor 
Affiliation  Hassan Institute Of Medical Sciences 
Address  Department of Dermatology,Venereology and Leprosy1st floor room no 14,Hassan institute of medical sciences campus, Hassan

Hassan
KARNATAKA
573201
India 
Phone  9480303929  
Fax    
Email  drsureshhsn@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ashrita Krishna 
Designation  Post graduate student 
Affiliation  Hassan Institute Of Medical Sciences 
Address  Department of Dermatology,Venereology and Leprosy1st floor room no 14,Hassan institute of medical sciences campus, Hassan

Hassan
KARNATAKA
573201
India 
Phone  9632221374  
Fax    
Email  ashrita.kr@gmail.com  
 
Source of Monetary or Material Support  
Department of Dermatology,Venereology and Leprosy1st floor room no 14,Hassan institute of medical sciences campus, Hassan  
 
Primary Sponsor  
Name  Ashrita Krishna 
Address  Department of Dermatology,Venereology and Leprosy1st floor room no 14,Hassan institute of medical sciences campus, Hassan  
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 Ashrita Krishna  Hassan institute of medical sciences  Room no 14,1st floor,Department of Dermatology,Venereology andLeprosy,Hassan institute of medical sciences, Hassan
Hassan
KARNATAKA 
9632221374

ashrita.kr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Etthics Committee-HIMS HASSAN  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  Inj Tranexamic acid  4 mg/ml of TXA,intradermal injections of TXA was administered over the hyper-pigmented patches, separating each prick with a 1 cm distance injecting one unit from insulin syringe in 1 cm area.Based on the area of involvement injections were given, the total dose not exceeding 16 mg of intradermal TXA. Five such sessions were administered at intervals of 4 weeks. For a duration of 5 months 
Comparator Agent  nil  nil 
Intervention  Platelet rich plasma  intradermal injection of PRP ,one unit from insulin syringe,injected into the melasma areas at 1 cm interval. Every 4 weeks (0, 4, 8, 12, 16 for five months 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1)Either gender
2) Age range of 20 to 50 years
3)Patients suffering from melasma.
4)Patients who didn’t respond to conventional topical therapy for melasma 
 
ExclusionCriteria 
Details  1)Pregnancy and lactation
2)patients with known platelet dysfunction
3)Those with prior history of allergy to tranexamic acid (may june)
4)Intake of any photosensitizing drugs
5) Known allergy to TXA.
6) Women on oral contraceptive pills and hormone replacement therapy.
7) Patients on any topical therapy for melasma in the past 3 months.
8) Critical thrombocytopenia less than 50,000/mcl.
9)Any history of hemodynamic instability.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of intralesional Tranexamic acid versus intralesional Inj platelet rich plasma in the treatment of melasma.
 
20 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   03/08/2025 
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="6"
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 affects the psychological, emotional, and social well-being of a person, impacting their quality of life. 

The current treatment modalities are associated with their own disadvantages.Hence, there is a need for newer modalities of treatment 

This study will be conducted on all consenting male and female patients with melasma.A study population consisting of 44 satisfying the inclusion and exclusion criteria will be recruited. With the informed consent obtained from the patients, a detailed history and examination will be done with the help of a predesigned proforma. Melasma will  be diagnosed by history and clinical features. Baseline evaluation was made at the first visit, and the demographic data were recorded in a structured questionnaire designed for this study.

Before treatment and at each follow-up appointment, clinical pictures were taken.Clinical photographs were taken at each visit and reduction in Modified Melasma Area and Severity Index (mMASI) was assessed at each visit. Response was graded as:

0. No response

1. Partial or fair response (0%-25% reduction)

2. Good response (26%-50% reduction)

3. Very good response (51%-75% reduction)

4. Excellent (>75% reduction)

 

All patients fulfilling the inclusion criteria were categorized into two groups depending on the treatment they received, namely, Group A (intralesional tranexamic acid) and Group B (platelet rich plasma) (n=22 per group )

Both Inj tranexamic acid and PRP are available at the institution.

 

Group A : Two units of TXA was drawn in a 40 U/ml 30 G insulin syringe and diluted with normal saline upto 1 ml (remaining 38 U out of total40 U) in order to obtain a concentration of 4 mg/ml of TXA. The face was numbed with ice packs that were kept for a period of 5–10 min, followed by cleansing with alcohol swabs, after which intradermal injections of TXA was administered over the hyper-pigmented patches, separating each prick with a 1 cm distance.Based on the area of involvement injections were given, the total dose not exceeding 16 mg of intradermal TXA. Five such sessions were administered at intervals of 4 weeks and advice regarding stringent photoprotection stated. All patients were prescribed sunscreen with  for the entire duration of treatment.

 

Group B :The antecubital fossa of each patient was cleansed with an alcohol swab following which 10 ml of venous blood was withdrawn from that region. The blood was centrifuged to obtain PRP. We obtained approximately 11.2 ml of PRP from 10 ml of whole blood. This was immediately injected into the  melasma areas at 1 cm interval, following numbing and cleansing of the face as described for TXA.

 

In each group clinical photographs were taken at baseline and at every 4 weeks (0, 4, 8, 12, 16, and 20 weeks) until the end of the study period for evaluation of therapeutic outcome and adverse effects

 
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