| CTRI Number |
CTRI/2023/09/057178 [Registered on: 01/09/2023] Trial Registered Prospectively |
| Last Modified On: |
29/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To know the bettertreatment for melasma skin disease intralesional tranexamic acid or glycolic acid chemical peel |
|
Scientific Title of Study
|
A comparative study on safety and efficacy of intralesional tranexamic acid versus 50% glycolic acid chemical peel in the treatment of melasma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MADESHWARI M |
| Designation |
Junior resident |
| Affiliation |
Chengalpattu medical college and hospital |
| Address |
Department of DVL
Chengalpattu medical college and hospital
Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9566390496 |
| Fax |
|
| Email |
murugeshmadhu7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.V.Jayakalyani |
| Designation |
Assistant professor |
| Affiliation |
Chengalpattu medical college and hospital |
| Address |
Department of DVL
Chengalpattu medical college and hospital
Chengalpattu
TAMIL NADU
603001
India |
| Phone |
8248829918 |
| Fax |
|
| Email |
dermcliniccmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MADESHWARI M |
| Designation |
Junior resident |
| Affiliation |
Chengalpattu medical college and hospital |
| Address |
Department of DVL
Chengalpattu medical college and hospital
Chengalpattu
TAMIL NADU
603001
India |
| Phone |
9566390496 |
| Fax |
|
| Email |
murugeshmadhu7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of DVL, Chengalpattu medical College and hospital |
|
|
Primary Sponsor
|
| Name |
Madeshwari M |
| Address |
Chengalpattu medical College and hospital |
| 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 |
| DrMadeshwari M |
Chengalpattu medical College and hospital |
No:44,Department of DVL,Chengalpattu medical College and hospital, Chengalpattu
Kancheepuram
TAMIL NADU |
9566390496
murugeshmadhu7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chengalpattu institute of ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, (2) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group B:20 patients 50% Glycolic acid peel |
50% glycolic acid chemical peel once in two weeks for 5weeks |
| Intervention |
Intresional tranexamic acid |
4mg per millilitre injection tranexamic acid injected intralesionaly once in two weeks for 5 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Before starting the study
Pregnant & lactating mothers Patients on oral contraceptive pills, hormonal replacement therapy Active infection /inflammationPhotosensitivity disorders (SLE, porphyria) History of bleeding disorder /Anticoagulant treatment History of allergy Any other mode of treatment for melasma prior to the study
During the Study:
Develops side effects during the treatment patient wants to discontinue the treatment |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the resolution of hyperpigmentation |
Baseline,week 4, week 8, week 12 and week 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess modified MASI score |
Baseline, week 12 and week 24 |
|
|
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 4 |
|
Date of First Enrollment (India)
|
08/09/2023 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
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 acquired hyperpigmentation disorder, various treatment modalities are available Management is difficult because it’s frequent relapse. Recently studies shows intralesional tranexamic acid a hemostatic agent,has hypopigmentary effect on melasma lesions Hence, my aim of study is to compare safety and efficacy of intralesional tranexamic acid versus 50%glycolic acid chemical peel |