| CTRI Number |
CTRI/2022/12/047814 [Registered on: 01/12/2022] Trial Registered Prospectively |
| Last Modified On: |
29/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Tranexamic acid in Melasma |
|
Scientific Title of Study
|
Microneedling with Topical Tranexamic acid and Topical Hydroquinone versus Microneedling and Topical Hydroquinone for treatment of Melasma : Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nagbhushan Hegde |
| Designation |
Junior Resident |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of Dermatology
AIIMS Jodhpur
Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7795209027 |
| Fax |
|
| Email |
nbhushan15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupama Bains |
| Designation |
Associate Professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
Dept Dermatology
AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7297895727 |
| Fax |
|
| Email |
doc.trinity@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Nagbhushan Hegde |
| Designation |
Junior Resident |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of Dermatology
AIIMS Jodhpur
Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7795209027 |
| Fax |
|
| Email |
nbhushan15@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS JODHPUR
Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005 |
|
|
Primary Sponsor
|
| Name |
AIIMS JODHPUR |
| Address |
All India Institute of Medical Sciences
Basni, Jodhpur
Rajasthan |
| Type of Sponsor |
Government 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 |
| Nagbhushan Hegde |
AIIMS Jodhpur |
Department of Dermatology
AIIMS Jodhpur
Jodhpur
Jodhpur
RAJASTHAN |
7795209027
nbhushan15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS JODHPUR |
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 |
| Comparator Agent |
Normal Saline |
Normal saline is applied over other side |
| Intervention |
Tranexamic Acid |
Topical 10% Tranexamic acid (2ml) is applied over one side after microneedling at 0 week, 4 week and 12 week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
All melasma patients with bilateral symmetrical melasma are included |
|
| ExclusionCriteria |
| Details |
Irregular menstruation
Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of topical Tranexamic acid will be assessed compared to normal saline using modified MASI score |
At 4 weeks, 8 weeks, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Side effects, change in mMASI,Physician Global Assesment |
4 weeks, 8 weeks, 12 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
07/12/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We are comparing the efficacy and side effect profile of topical tranexamic acid in treatment of melisma. The efficacy of oral tranexamic acid is known from the literature. We are trying to establish the efficacy of topical Tranexamic acid with microneedling |