| CTRI Number |
CTRI/2017/07/009158 [Registered on: 28/07/2017] Trial Registered Retrospectively |
| Last Modified On: |
19/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to compare efficacy of intradermal Tranexamic acid injections versus topical Tranexamic acid gel versus topical triple combination (Hydroquinone 2 %, Tretinion 0.025%, Flucinolone acetonide 0.01%) cream in patients suffering from melasma |
|
Scientific Title of Study
|
The comparative study of the efficacy of intradermal tranexamic acid V/S 3% topical tranexamic acid V/S topical triple combination (hydroquinone 2 %, tretinion 0.025%, flucinolone acetonide 0.01%) in melasma. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shruti Patil |
| Designation |
Junior Resident |
| Affiliation |
Mahatma Gandhi Missions Medical College & Hospital |
| Address |
Skin & VD Department, Basement Floor OPD building MGM Medical COllege and hospital N-6 CIDCO Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
7588062880 |
| Fax |
02402487727 |
| Email |
shruti04patil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Deshmukh |
| Designation |
Professor and head |
| Affiliation |
Mahatma Gandhi Missions Medical College & Hospital |
| Address |
Skin and VD department basement floor OPD building MGM Medical College and hospital N-6 CIDCO Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9422213292 |
| Fax |
02402487727 |
| Email |
ashish7557@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Patil |
| Designation |
Junior Resident |
| Affiliation |
Mahatma Gandhi Missions Medical College & Hospital |
| Address |
Skin and VD Department MGM Medical College and hospital N-6 CIDCO Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
7588062880 |
| Fax |
02402487727 |
| Email |
shruti04patil@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Medical College and Hospital N6 Cidco Aurangabad 431003 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
MGM Medical COllege and Hospital |
| Address |
N6 CIDCO Aurangabad Maharashtra India |
| 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 Shruti Patil |
MGM Medical College and Hospital |
Skin and VD department basement floor OPD building MGM Medical College and Hospital
N6 CIDCO Aurangabad Maharashtra India
Aurangabad
MAHARASHTRA |
7588062880
02402487727
shruti04patil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM-ECRHS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L818||Other specified disorders of pigmentation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hydroquinone 2%
Tretnion 0.025%
Fluocinolone acetonide 0.01% |
Topical cream to be applied as a thin layer once a day at night, over affected area for 6 months |
| Comparator Agent |
Topical 3% Tranexamic acid |
Topical gel to be applied as a thin layer once a day at night, over affected area for 6 months |
| Intervention |
Tranexamic acid |
Dose- 0.05 ml (4mg/ml) in each cm sq of melasma,Mode of Administration intradermal, Frequency-once in every 15 days, Duration of
treatment-03 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 All melasma patients
2 Willing to give written inform consent |
|
| ExclusionCriteria |
| Details |
1 Patients with hypersensitivity to drugs
2 Pregnant and lactating patient
3 Patients with clotting disorders or patients who are on anticoagulant therapy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 To study the efficacy of intradermal tranexamic acid versus topical tranexamic acid versus topical triple combination |
Every Month for 06 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study adverse effects of study drugs
|
Every month for 06 months |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
26/12/2016 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1. Ebrahimi B, Naeini FF. Topical tranexamic acid as a promising treatment for melasma. Journal of Research in Medical Sciences : The Official Journal of Isfahan University of Medical Sciences. 2014;19(8):753-757.2. Bhawan J, Grimes P, Pandya AG,Keady M, Nyers HR, Guevara IL, et al. A histological examination of skin atropy after 6 months of treatment with fluocinolone acetonide 0.01%, hydroquinone 4% and tretinion 0.05% cream. American Journal of Dermatopathology: December 2009 - Volume 31 - Issue 8 - pp 794-798 |