| 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
|
|
|
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
|
|
|
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 1–1.2 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 |