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CTRI Number  CTRI/2018/07/014952 [Registered on: 18/07/2018] Trial Registered Prospectively
Last Modified On: 20/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To assess the effect of Tranexamic acid in cure of a pigment disorder  
Scientific Title of Study   Effectiveness of Tranexamic acid in the treatment of Melasma - A randomized controlled 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  Dr Snehalatha 
Designation  Consultant -Dermatology 
Affiliation  Hindu Mission Hospital 
Address  Room No:32 Dermatology Clinic, Hindu Mission Hospital, No:103 GST Road, West Tambaram,Chennai.
No:103 GST Road, West Tambaram,Chennai.
Chennai
TAMIL NADU
600045
India 
Phone  9941939309  
Fax    
Email  dr_snehalatham@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Melvin George 
Designation  Consultant-Clinical Research Department 
Affiliation  Hindu Mission Hospital 
Address  Room No:101, Clinical Research, Hindu Mission Hospital, No:103 GST Road, West Tambaram,Chennai.
No:103 GST Road, West Tambaram,Chennai.
Chennai
TAMIL NADU
600045
India 
Phone  9894133697  
Fax    
Email  melvingeorge2003@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Melvin George 
Designation  Consultant-Clinical Research Department 
Affiliation  Hindu Mission Hospital 
Address  Room No:101, Clinical Research, Hindu Mission Hospital, 103, GST Road, West Tambaram,Chennai.
No:103 GST Road, West Tambaram,Chennai-45.
Chennai
TAMIL NADU
600045
India 
Phone  9894133697  
Fax    
Email  melvingeorge2003@gmail.com  
 
Source of Monetary or Material Support  
Hindu Mission Hospital, No:103 GST Road, West Tambaram,Chennai-45. 
 
Primary Sponsor  
Name  Hindu Mission Hospital 
Address  102, GST road, West Tambaram. 
Type of Sponsor  Private hospital/clinic 
 
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 
DrSnehalatha  Hindu Mission Hospital  Room No:32, Dermatology Clinic, Hindu Mission Hospital, 103 GST Road West Tambaram, Chennai-45
Chennai
TAMIL NADU 
9941939309

dr_snehalatham@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Hindu Mission Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Melasma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hhlite  Mometasone Furoate I.P 0.1% + tretinoin 0.025%+hydroquinone 2.0%, topically used once daily for three months. 
Intervention  Tranexamic acid   500mg Per ora once daily for three months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.Patients with diagnosis of melasma .
2.Age 18 - 55 years, of either gender.
3.Absence of other confounding inflammatory dermatoses (eg. Exogenous ochronosis, Acanthosis nigricans, post inflammatory hyperpigmentation, Pigmented cosmetic dermatitis, Actinic lichen planus, malar rash, etc.)
4.Willing to follow the study procedures and give written informed consent.
 
 
ExclusionCriteria 
Details  1.Pregnancy and lactation.
2.Any chronic medical illness,
3.History of thrombosis, abnormal bleeding profile,
4.Any medical treatment for melasma within 1 month of entry,
5.Skin resurfacing by dermabrasion, chemical peels, and facial laser within the preceding 9 months,
6.Hypersensitivity to TXA,
7.Abnormal bleeding time, clotting time or platelet count 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
MASI Score  90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Occurrence of adverse effects.
Patients satisfaction will be evaluated by a Visual Analogic Scale
 
90 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   23/07/2018 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
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)?  

Brief Summary  

Melasma is a common pigment disorder that manifests as symmetric hyper-pigmented macules  on the face mostly on the malar areas of cheek and on forehead and chin and most commonly occurs in women of darker skin color.It typically affects women of reproductive age with skin type IV-VI . Current treatments using topical steroids such as superficial peels Lactic acid glycolic acid , trichlor acetic acid, kojic acid, Lasers and retinoids, demonstrate variable efficacy and side-effect profiles. Despite the plethora of treatment , melasma poses a great challenge as its treatment can be often unsatisfactory with high recurrence rate . The pathogenesis of melasma remains poorly understood and its treatment continues to be challenging with approximately 10% cases occurring in men. The disease prevalence among Asians is about 40% in females and about 20% in males. Melasma is the most common pigmentary disorder in India, with incidence of approximately 10%. It is also found to occur at a younger age among Indians. 

Newer formulation that are being tried include tranexamic acid (TA), a well-known Anti-fibrinolytic agent, in the treatment of melasma, which is a plasmin inhibitor used to prevent abnormal fibrinolysis to reduce blood loss. Tranexamic acid is a pro-coagulant agent that is approved by the US Food and Drug Administration for treatment of Menorrhagia and to prevent hemorrhage, it also mitigates the UV radiation-induced pigmentation response. Challenges to the use of tranexamic acid for melasma treatment in a medico-legal environment, specifically the risks associated with using a pro-coagulant medication for a cosmetic indication. Melanocytes cultured in media were found to have decreased tyrosinase activity and reduced melanin content when treated with tranexamic acid.

 
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