| 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 |
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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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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 |
|
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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 |
|
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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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 |
|
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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 |
|
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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" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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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