| CTRI Number |
CTRI/2025/08/092525 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Randomised Control Study Comparing Intradermal Tranexamic Acid and Intradermal Platelet-Rich Plasma For The Treatment Of Melasma |
|
Scientific Title of Study
|
Intradermal Tranexamic Acid Vs Intradermal Platelet-Rich Plasma In The Treatment Of Melasma- A Randomised Control Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Simran Jain |
| Designation |
PG Resident |
| Affiliation |
Krishna Mohan Medical College and Hospital |
| Address |
Room no- 67, Department of Dermatology, Venereology and Leprosy,Krishna mohan medical college and hospital, K.M University,
Pali Dungra, Sonkh Road,
Mathura, Uttar Pradesh
Mathura
UTTAR PRADESH
281123
India |
| Phone |
9811105831 |
| Fax |
|
| Email |
simranjainmd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ram Awatar Bumb |
| Designation |
H.O.D. and Professor |
| Affiliation |
Krishna Mohan Medical College and Hospital |
| Address |
Room no- 67,Department of Dermatology, Venreology and Leprosy,Krishna mohan medical college and hospital,
Pali Dungra, Sonkh Road,
Mathura, Uttar Pradesh
Mathura
UTTAR PRADESH
281123
India |
| Phone |
9811105831 |
| Fax |
|
| Email |
dr_bumb@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simran Jain |
| Designation |
PG Resident |
| Affiliation |
Krishna Mohan Medical College and Hospital |
| Address |
Room no- 67, Department of Dermatology, Venereology and Leprosy,Krishna mohan medical college and hospital, K.M University,
Pali Dungra, Sonkh Road,
Mathura, Uttar Pradesh
Mathura
UTTAR PRADESH
281123
India |
| Phone |
9811105831 |
| Fax |
|
| Email |
simranjainmd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no- 67, Department of Dermatology, Venereology and Leprosy,Krishna mohan medical college and hospital, K.M University,
Pali Dungra, Sonkh Road,
Mathura, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Krishna Mohan Medical College and Hospital |
| Address |
Room no- 67, Department of Dermatology, Venereology and Leprosy,Krishna mohan medical college and hospital, K.M University,
Pali Dungra, Sonkh Road,
Mathura, Uttar Pradesh |
| Type of Sponsor |
Private medical college |
|
|
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 Simran Jain |
Krishna Mohan Medical College and Hospital |
Department of Dermatology Venereology and Leprosy
Krishna Mohan Medical College and Hospital
Pali Dungra Sonkh Road
Mathura Uttar Pradesh
Mathura
UTTAR PRADESH |
9811105831
simranjainmd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K.M UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE |
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 |
Intradermal Platelet Rich Plasma (PRP) |
PRP will be used for the treatment of Melasma over a period of 4 months. It is a relatively newer treatment modality for melasma. |
| Comparator Agent |
Intradermal Tranexamic Acid (TXA) |
TXA will be used for the treatment of melasma over a period of 4 months. It is a relatively established treatment modality for melasma. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ADULT PATIENTS WITH EPIDERMAL OR DERMAL OR MIXED MELASMA. |
|
| ExclusionCriteria |
| Details |
Patients who have used any form of melasma treatment, whether oral or topical, within the previous 3 months.
Patients with established platelet dysfunction disorder.
Patients on oral contraceptive pills.
Known cases of bleeding disorders.
Pregnant women.
Breastfeeding females.
Patients on anticoagulants. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
Erythema
Inflammation |
1, 2, 3, 4, 7 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hypopigmentation
Recurrence
Post inflammatory hyperpigmentation |
7 MONTHS |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
29/08/2025 |
| 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="10"
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, multifactorial hyperpigmentation disorder that negatively impacts quality of life. While many topical and procedural treatments exist for this condition, a definitive therapy remains elusive. The study focuses on two modern intradermal therapies Tranexamic Acid (TXA), which inhibits UV induced plasmin activity in keratinocytes, and Platelet Rich Plasma (PRP), which uses growth factors like TGF beta1 to inhibit melanin synthesis. The existing literature provides conflicting results from previous studies comparing these two modalities, thereby establishing the need for further research. The primary aim of the study is to compare the efficacy of intradermal TXA versus intradermal PRP in the treatment of melasma. The objectives are to evaluate the effectiveness of each treatment individually and then to compare the outcomes of the two treatment arms. This will be a randomized prospective interventional study. We will enroll 40 patients who will be randomized into two groups of 20 each. Group A will receive intradermal injections of TXA. Group B will receive intradermal injections of autologous PRP. The treatment will consist of a maximum of four sessions administered at four weekly intervals for both groups. Patients aged 18 to 50 years are eligible for inclusion , while those who are pregnant, breastfeeding, on oral contraceptives, or have bleeding disorders are among those who will be excluded. The primary outcome will be the evaluation of efficacy via the modified Melasma Area and Severity Index (mMASI) score. Written informed consent will be obtained from all participants. |