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CTRI Number  CTRI/2024/09/073872 [Registered on: 13/09/2024] Trial Registered Prospectively
Last Modified On: 30/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Which works better in melasma patients modified kligman with oral tranexamic acid or modified kligman alone  
Scientific Title of Study   A comparative study of modified kligman regimen versus combination of modified kligman with oral tranexamic acid in the treatment of melasma  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anuradha Gupta 
Designation  Junior Resident 
Affiliation  Peoples college of medical science and research center  
Address  OPD 8,Dermatology Department,Peoples College Of Medical Science and Research Centre Ayodhya Bypass Rd ,Bhanpur,Bhopal

Bhopal
MADHYA PRADESH
462037
India 
Phone  8770329234  
Fax    
Email  anuradhaguptamodi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek Kumar Dey 
Designation  Professor 
Affiliation  Peoples college of medical science and research center  
Address  OPD 8,Dermatology Department,Peoples College Of Medical Science and Research Centre Ayodhya Bypass Rd ,Bhanpur,Bhopal

Bhopal
MADHYA PRADESH
462037
India 
Phone  9981346039  
Fax    
Email  dermatology.hod@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr anuradha gupta 
Designation  Junior Resident 
Affiliation  Peoples college of medical science and research center  
Address  OPD 8,Dermatology Department,Peoples College Of Medical Science and Research Centre Ayodhya Bypass Rd ,Bhanpur,Bhopal

Bhopal
MADHYA PRADESH
462037
India 
Phone  08770329234  
Fax    
Email  anuradhaguptamodi@gmail.com  
 
Source of Monetary or Material Support  
Data will be collected at OPD 8,Dermatology Department,Peoples College Of Medical Science and Research Centre Ayodhya Bypass Rd ,Bhanpur,Bhopal,Madhya Pradesh,India 462037 Self Funding will be done 
 
Primary Sponsor  
Name  Dr Anuradha Gupta 
Address  OPD 8,Dermatology Department,Peoples College Of Medical Science and Research Centre Ayodhya Bypass Rd ,Bhanpur,Bhopal,MadhyaPradesh,India,462037 
Type of Sponsor  Other [Self funding] 
 
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 
Dr Anuradha Gupta   Peoples College Of Medical Science and Research Centre   OPD 8,Dermatology Department, Ayodhya Bypass Rd ,Bhanpur,Bhopal,462037
Bhopal
MADHYA PRADESH 		 8770329234

anuradhaguptamodi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical commitee of peoples college of medical science and research centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L811||Chloasma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  modified kligman regimen   localapplication of modified kligman regimen over lesion for 2 hrs at night for total duration of 3 months 
Intervention  oral tranexamic acid with modified kligman regimen   oral tranexamic acid 250 mg 12 hrly with local application of modified kligman regimen over lesion for 2 hrs at night for total duration of 3months 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  :

1- Patients aged between 20 to 60yrs.

2- Patients diagnosed with Melasma and not taking oral/topical medication in last 3 months.

3- Patients who give consent for study. 
 
ExclusionCriteria 
Details  1. H/o Thrombotic events, Stroke, Myocardial Infarction.

2. Pregnant women, menstrual irregularities.

3. Patients taking oral contraceptives

4. Patients with sensitive skin (burning sensation, allergic to any topical creams).

5. Photosensitivity disorders (SLE, porphyria, drugs).

6. Underwent any recent surgeries within a period of (3 months) and undergoing any cosmetic procedure.

7. Patients not willing to participate in study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
age
duration
gender
type of melasma
location of melasma
size of lesion
MSI score
 		 start of therapy 
 
Secondary Outcome  
Outcome  TimePoints 
age
duration
gender
type of melasma
location of melasma
size of lesion
MSI score 		 at the end of 12 th week 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
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)   20/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/09/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Not yet recruiting .waiting  for ctri registration .Melasma  also known as chloasma is a  hyper pigmentary disorder which commonly affects face. Melasma is one of the most common pigmentary disorder in dermatology clinic. Females are more commonly affected than males in the ratio of 9:1.Exact etiology of this disorder is unknown. However cause is multifactorial and it includes sun exposure ,pregnancy, drugs, harmonal imbalance etc.Excessive sun exposure is the most common cause.Approximately 20 percent of pregnant female develop melasma during pregnancy and hardly regress after pregnancy.
melasma posses cosmetic as well siginificant negative impact on patients quality of life. At present the treatment modalities available are topical agents ,lasers ,chemical peels, microneedling  etc. Procedures are expensive and need follow ups and multiple visits. Hence, There is need to research for an effective therapeutic agent which is cheap ,give a better outcome and without causing major side effects.
Modified kligman regimen is a standard treatment to treat melasma. This regimen take long time to treat melasma .Hence, trenaxemic acid was selected for this study to reduce the  duration of treatment. Trenaxamic acid is an antifibrinolytic which is extensively used to treat menorrhagia. It acts by inhibiting plasminogen activator and interfere with production of melanin, thereby reducing the hyperpigmentation of melasma.
Hence,this study will be done to investigate whether oral trenaxamic acid is add on to standard therapy i.e.modified kligman regimen is effective in the treatment of melasma.
 
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