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CTRI Number  CTRI/2019/07/020340 [Registered on: 23/07/2019] Trial Registered Prospectively
Last Modified On: 21/07/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Oral tranexamic acid in the treatment of moderate to severe melasma. 
Scientific Title of Study   A randomized, open label study of two different dosage regimens of oral tranexamic acid in the treatment of moderate to severe melasma 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Muthu Sendhil Kumaran 
Designation  Additional Professor 
Affiliation  PGIMER Chandigarh 
Address  Faculty offices, F block, Nehru Hospital, PGIMER Sector 12
Sector 12
Chandigarh
CHANDIGARH
160012
India 
Phone  8872004023  
Fax    
Email  drsen_2000@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Muthu Sendhil Kumaran 
Designation  Additional Professor 
Affiliation  PGIMER Chandigarh 
Address  Faculty offices, F block, Nehru Hospital, PGIMER Sector 12
Sector 12

CHANDIGARH
160012
India 
Phone  8872004023  
Fax    
Email  drsen_2000@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Muthu Sendhil Kumaran 
Designation  Additional Professor 
Affiliation  PGIMER Chandigarh 
Address  Faculty offices, F block, Nehru Hospital, PGIMER Sector 12
Sector 12

CHANDIGARH
160012
India 
Phone  8872004023  
Fax    
Email  drsen_2000@yahoo.com  
 
Source of Monetary or Material Support  
Faculty Offices, F block, Nehru Hospital, 4th floor, PGIMER Chandigarh 
 
Primary Sponsor  
Name  PGIMER Chandigarh 
Address  C/O Dr. Muthu Sendhil Kumaran, Faculty Offices, F bLOCK, 4th Floor, Nehru Hospital, PGIMER 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
M Sendhil Kumaran  PGIMER Chandigarh  Skin OPD, 5TH Level, C Block, New OPD Block, PGIMER, Chandigarh
Chandigarh
CHANDIGARH 
8872004023

drsen_2000@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oral tranexemic acid   Oral tranexemic acid 250 mg twice a day for 3 months 
Comparator Agent  Oral tranexemic acid   Oral tranexemic acid 500 mg twice a day for 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Female and male patients aged more than 18 years with moderate to severe melasma (Moderate melasma will be defined as melasma patients with mMASI score of 5.8 to 7.9 and severe melasma as those with mMASI ≥ 8 based on defined ranges for melasma severity.46  
 
ExclusionCriteria 
Details  1. Known drug hypersensitivity to TXA.
2. Patients on medications for cardiovascular, gastrointestinal, hepatic, renal, disorders.
3. Pregnant or lactating mothers
4. Patients having history of hypercoagulable disorders or history of thrombotic episodes like deep vein thrombosis, pulmonary embolism, cerebral vein thrombosis.
5. Patients taking oral contraceptive pills.

 
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. The primary objective is to evaluate and compare the efficacy of two different dosing regimens of TXA, that is, 250 mg twice daily versus 500 mg twice daily, using the mMASI score. The proportion of patients achieving mMASI 75 assesses the efficacy.

 
Baseline, monthly for 6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Proportion of patients achieving mMASI 90
2. To assess the dose of TXA that acts faster (time to achieve mMASI 75) and prevents relapse while on maintenance therapy.
3. Change in MELASQOL index over the six month study period.
4. Duration of treatment
5. Adverse events, if any, due to TXA

 
baseline, 3 months, 6 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/09/2020 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Melasma is a common, acquired disorder of hyperpigmentation affecting millions of people worldwide. It causes tremendous impact on the self esteem and quality of life of the affected people, especially females. While various topical agents have so far been the mainstay of treatment of melasma, they are plagued by side effects as well relapse and recurrences omce they are stopped. Oral tranexemic acid (TXA) is the latest tool in the armamentarium of melasma treatment. It has so far been used in various forms including oral, topical and injectable with variable but promising results. However, the dosing of TXA in melasma has been a cause of persistent speculation and this puzzle is what our study aims to shed some light on. Doses of TXA used for melasma in studies to date have ranged from 500 to 1,500mg daily.45 A typical dose is 250 mg twice daily. Treatment is usually continued for 8 to 12 weeks.45 This is in contrast to menorrhagia for which the dose is 3.9 to 4 g daily for up to 5 days per month.34 However, there is still no consensus to guide the dose and duration of therapy. There is also not much clarity on the risk of relapse after stopping oral TXA and if maintenance treatment is required and if so, if the duration of maintenance regimen differes with different dosages of TXA. Studies have documented safe useof TXA for menorrhagia over the years with only minor side effects like nasal and sinus discomfort, back pain, musculoskeletal pain, oligomenorrhea, and abdominal cramps, with no evidence of ocular toxicity.22, 34, 35 Hence, at the dosages currently employed  and based on available data, it seems unlikely that TXA would increase risk of thrombotic complications, more so in the indications for which it is used in dermatology.

The present study is designed as a randomized, open label study in which 50 patients suffering from moderate to severe melasma according to the mMASI scores will be recruited and be divided into two arms to receive oral tranexemic acid at a dose of 250 mg twice a day or 500 mg twice a day for 12 weeks along with a sunscreen of SPF 30+.  The primary objective is to evaluate and compare the efficacy of the two different dosing regimens of TXA, that is, 250 mg twice daily versus 500 mg twice daily, using the mMASI score. The proportion of patients achieving mMASI 75 will be used as the proxy measure to assess the efficacy. The secondary aims will include assessing the MELASQOL score of the patients at baseline and the end of treatment to have an objective analysis of the impairment of quality of life caused by melasma, apart from noting any adverse effects, if any.


 

 
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