| CTRI Number |
CTRI/2024/03/064275 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
04/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the effect of tranexamic acid needling versus tranexamic acid injections in melasma |
|
Scientific Title of Study
|
Split face study comparing efficacy of microneedling with tranexamic acid versus microinjections with tranexamic acid in melasma in Indian skin
|
| 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 V JAYAMALIGA |
| Designation |
SENIOR RESIDENT |
| Affiliation |
VINAYAKA MISSIONS MEDICAL COLLEGE, KARAIKA |
| Address |
DEPARTMENT OF DERMATOLOGY VINAYAKA MISSIONS MEDICAL COLLEGE
KARAIKAL
PONDICHERRY
609609
India
Karaikal
PONDICHERRY
609609
India |
| Phone |
9952271080 |
| Fax |
|
| Email |
j.maliga92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR V SIVASUBRAMANIAN |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
VINAYAKA MISSIONS MEDICAL COLLEGE KARAIKAL |
| Address |
DEPARTMENT OF DERMATOLOGY VENEREOLOGY AND LEPROSY
VINAYAKA MISSIONS MEDICAL COLLEGE
KARAIKAL
PONDICHERRY
609609
India
Karaikal
PONDICHERRY
609609
India |
| Phone |
9884835199 |
| Fax |
|
| Email |
hoddvdvmmckkl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V JAYAMALIGA |
| Designation |
SENIOR RESIDENT |
| Affiliation |
VINAYAKA MISSIONS MEDICAL COLLEGE, KARAIKA |
| Address |
DEPARTMENT OF DERMATOLOGY VINAYAKA MISSIONS MEDICAL COLLEGE
KARAIKAL
PONDICHERRY
609609
India
Karaikal
PONDICHERRY
609609
India |
| Phone |
9952271080 |
| Fax |
|
| Email |
j.maliga92@gmail.com |
|
|
Source of Monetary or Material Support
|
| VINAYAKA MISSIONS MEDICAL COLLEGE
KARAIKAL
PONDICHERRY |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Medical College |
| Address |
Keezhakasakudymedu, Karaikal, Pondicherry |
| 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 V JAYAMALIGA |
VINAYAKA MISSIONS MEDICAL COLLEGE |
DEPARTMENT OF DERMATOLOGY
VINAYAKA MISSIONS MEDICAL
COLLEGE
KARAIKAL
PONDICHERRY
609609
Karaikal
PONDICHERRY |
9952271080
j.maliga92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VINAYAKA MISSIONS MEDICAL COLLEGE KARAIKAL INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L818||Other specified disorders of pigmentation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Microinjection with tranexamic acid in the treatment of melasma |
For patients with melasma microinjection with tranexamic acid given at baseline then every 2 weeks for a maximum of 6 session and followed up at monthly intervals for next 3 months |
| Intervention |
Microneedling with with tranexamic acid
in the treatment of melasma |
For patients with melasma
microneedling with tranexamic acid given at baseline
then every 2 weeks for a maximum of 6 session and followed up at
monthly intervals for next 3
months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical diagnosis of melasma
Patients who are
willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Patients allergic to Tranaxemic acid
Patients with predisposition to keloids
Pregnant and lactating mothers
Patients with history of bleeding disorders use of oral anticoagulant drugs
Patients under oral contraceptive pills hormonal replacement therapy at the time of or during the past 12 months of study
Patients with a history of treatment for melasma in the past 6 weeks in any form
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Compare the clinical response by mMASI and PtGA score
to microneedling with tranexamic acid
and microinjections with tranexamic acid in treatment of melasma
|
every 2 weeks for 3 months, and at the end of 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Treatment side effects |
Every 4 weeks for 3 months and at the end of 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
29/03/2024 |
| 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="1"
Months="0"
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
|
After applying inclusion and exclusion criteria .History and written consent from the patient is taken For Group A Patients Topical anesthesia will be applied over lesions under occlusion for 45 minutes Microneedling will be done with DermaPen using the lowest speed with the penetration depth of the needle from 0.25 to 1 mm This will be followed by application of about 0.5 ml TXA (4mg/mL) to the melasma area After cleaning with betadine topical fusidic acid applied under occlusive dressing for the same day All patients will be advised to use sunscreens regurarly The procedure will be repeated every 2 weeks for a maximum of 6 sessions For Group B Patients Topical anesthesia will be applied over lesions under occlusion for 45 minutes Intradermal microinjection of about 4 mg/mL Tranexamic acid will be given in 1 mL insulin syringe with 30 gauge needle Keeping a distance of around 1 cm from each injection with a maximum of 8 mg in a single sitting After cleaning with betadine topical fusidic acid applied under occlusive dressing for the same day All patients will be advised to use sunscreens regularly The procedure will be repeated every 2 weeks for a maximum of 6 session Clinical improvement and side effects will be assessed after each session and at the end of 6 months The study will be concluded with the comparison of clinical improvement of both group A and group B study population
|