| CTRI Number |
CTRI/2022/07/044450 [Registered on: 28/07/2022] Trial Registered Prospectively |
| Last Modified On: |
22/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
compare the results of tablet and injection tranexamic acid for pigmentation over face |
|
Scientific Title of Study
|
A compare the efficacy of oral tranexamic acid versus intralesional tranexamic acid in management 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 |
Eeshaan ranjan |
| Designation |
Assistant professor |
| Affiliation |
Military hospital Jammu |
| Address |
Dept. of Dermatology
Military hospital
Jammu
Jammu
JAMMU & KASHMIR
180003
India |
| Phone |
|
| Fax |
|
| Email |
eeshaan.ranjan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Eeshaan ranjan |
| Designation |
Assistant professor |
| Affiliation |
Military hospital Jammu |
| Address |
Dept of dermatology
Military hospital
Jammu
Jammu
JAMMU & KASHMIR
180003
India |
| Phone |
|
| Fax |
|
| Email |
eeshaan.ranjan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Eeshaan ranjan |
| Designation |
Assistant professor |
| Affiliation |
Military hospital Jammu |
| Address |
Dept of dermatology
Military hospital
Jammu
Jammu
JAMMU & KASHMIR
180003
India |
| Phone |
|
| Fax |
|
| Email |
eeshaan.ranjan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Military hospital, Satwari cantt
Jammu. 180003 |
|
|
Primary Sponsor
|
| Name |
Military hospital |
| Address |
Military hospital,
Satwari cantt
Jammu. 180003 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 eeshaan ranjan |
military hospital jammu |
military hospital jammu
Jammu
JAMMU & KASHMIR |
9720639323
eeshaan.ranjan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, MILITARY HOSPITAL, JAMMU |
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 |
oral tranexamic acid |
tranexamic acid 250 mg twice a day for 12 weeks |
| Intervention |
Tranexamic acid injection |
intradermal tranexamic acid injection, . 3 injections at an interval of 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18-60 years with clinical diagnosis of melasma.
|
|
| ExclusionCriteria |
| Details |
1. History of bleeding disorders
2. Patient taking oral anticoagulants, hormonal drugs like estrogen, progesterone, oral contraceptive pills and other female hormonal analogues.
3. Past or family history of thrombotic disease like DVT.
5. Patients with known allergy to tranexamic acid.
6. Pregnant and lactation mothers.
8. Patients with any other facial dermatoses.
9. History of any treatment for melasma in the past 6 months.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in mMASI score |
At presentation and follow-up at 4, 8 , 12 and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patient satisfaction score |
at presentation and 6 months after treatment |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/08/2022 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Melasma is a common pigmentary disorder. Tranexamic acid is a newer treatment modality and it can be used by various routes such as oral, topical and intradermal. Though oral route is effective, it is associated with various side effects and contraindications. Intradermal tranexamic acid is a new treatment modality owing to its fewer side effects. Thus, we plan to conduct a randomized, controlled trial in order to evaluate the safety and efficacy of intradermal injection of tranexamic acid and compare the results with oral tranexamic acid. Injection tranexamic acid is available as 500 mg/5 ml ampoule. It is diluted with normal saline to obtain a concentration of 25 mg/ml. In first arm, Intradermal injection of tranexamic acid will be injected 0.1 ml/cm2 into the melasma lesions. 3 injections will be
given intradermally at an interval of 4 weeks. In second arm, oral tranexamic acid 250 mg twice a day will be given for 12 weeks.
Clinical, dermoscopic and photographic assessment will be done at 4, 8, 12 and 24 weeks completion of treatment. The severity of melasma will be assessed by Modified MASI scoring at presentation and at completion of treatment.
|