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CTRI Number  CTRI/2017/10/010049 [Registered on: 09/10/2017] Trial Registered Retrospectively
Last Modified On: 06/10/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of two drugs, Tranexamic acid and Hydroquinone in patients with melasma 
Scientific Title of Study   A COMPARATIVE STUDY ON THE EFFICACY OF TOPICAL 5% TRANEXAMIC ACID SOLUTION VS 3% HYDROQUINONE CREAM 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 Manasa S J 
Designation  Post Graduate Student 
Affiliation  Command Hospital Airforce 
Address  Department of Dermatology, Command Hospital Airforce, Old Airport road, Agram Post, BANGALORE
Old Airport road, Agram Post, BANGALORE-560007
Bangalore
KARNATAKA
560007
India 
Phone  9844855195  
Fax    
Email  manasajanne@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S Radhakrishnan 
Designation  Professor and HOD 
Affiliation  Command Hospital Airforce 
Address  Department of Dermatology, Command Hospital Airforce, Old Airport road, Agram Post, BANGALORE
Old Airport road, Agram Post, BANGALORE-560007
Bangalore
KARNATAKA
560007
India 
Phone  9449275068  
Fax    
Email  drsrkskin@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manasa S J 
Designation  Post Graduate Student 
Affiliation  Command Hospital Airforce 
Address  Department of Dermatology, Command Hospital Airforce, Old Airport road, Agram Post, BANGALORE
Old Airport road, Agram Post, BANGALORE-560007
Bangalore
KARNATAKA
560007
India 
Phone  9844855195  
Fax    
Email  manasajanne@gmail.com  
 
Source of Monetary or Material Support  
Command Hospital Airforce Bangalore, Old Airport road, Bangalore-560007 
 
Primary Sponsor  
Name  Dr Manasa S J 
Address  Post Graduate Student, Department of Dermatology, Command Hospital Airforce, old airport road, BANGALORE560007 
Type of Sponsor  Other [Primary Investigator] 
 
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 
Manasa S J  Command Hospital Airforce Bangalore  Room number 5,Outpatient division, Department of Dermatology
Bangalore
KARNATAKA 
9844855195

manasajanne@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Command Hospital Airforce Bangalore  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  3% Hydroquinone cream  50 patients are asked to apply 3% Hydroquinone cream at night for 12 weeks 
Intervention  5% Tranexamic acid solution  50 patients of melasma are asked to apply 5% Tranexamic acid solution at night for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Previously treated cases of melasma,not applying topical medication for past 1 month. 
 
ExclusionCriteria 
Details  1. Pregnant and nursing women. 2.Women on OCPs 3.Patients on photosensitizing drug.4.Patients with clotting disorders 5. Patients on concurrent treatment for melasma. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in mean MASI score
 
0,4,8,12th week
 
 
Secondary Outcome  
Outcome  TimePoints 
No improvement in MASI score  12 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2016 
Date of Study Completion (India) 30/06/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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, frequently relapsing acquired hypermelanosis of sunexposed areas. It is common in darker skin types and has a female preponderance. The exact etiopathogenesis of melasma remains elusive and various factors like genetic predisposition, sun-exposure, hormones, vascular factors influence its development. Presently, there is no universally effective procedure or agent for melasma treatment despite the availability of various therapeutic modalities. However, hydroquinone has shown some benefits in melasma since last five decades. Melasma responds relatively slow to treatment and tends to recur. In view of the adverse effects associated with hydroquinone, its long term use is not recommended. A multitude of alternatives ranging from natural extracts to LASERs have been extensively investigated for melasma. Preliminary trials with tranexamic acid are encouraging and its efficacy at various strengths, formulations and types of melasma are being explored.

Our study aimed at assessing the efficacy of topical 5% tranexamic acid solution versus 3% hydroquinone cream in melasma. After obtaining informed consent and randomization into two intervention groups, 100 eligible patients of melasma were provided with the above mentioned preparations for once daily application for 12 weeks. MASI and photographs at baseline, weeks 4, 8 and 12 were documented. Subjective improvement was assessed at the end of the study by patient satisfaction score.

Our study population consisted of 84 females and 16 males with 35.86+ 7.40 years in males and 36.18+ 7.52 years in females. Majority of the patients developed melasma in the fourth decade of their lives and only 12% had an onset during pregnancy and in 12% it was associated with hypothyroidism. About 50% of the patients in this study belonged to Fitzpatrick skin type IV, followed by type V(46%). Mixed melasma had the highest prevalence(63%) followed by epidermal type in 22% and dermal type in 15% of the study population.

The mean MASI scores in TA and HQ groups at baseline were 12.39±3.34 and 11.63 ± 3.72 respectively and after 12 weeks of study were 9.47±2.79 and 9.24±3.26 respectively. Percentage reduction of MASI in TA group was 27% and in HQ group was 26.7% and the difference in the reduction between the two groups was not significant (P> 0.05). Patient satisfaction score, a tool for subjective assessment of improvement showed significantly better results in TA group(P value-0.03).

TA appears to be a promising agent in the treatment of melasma. However, large scale studies are needed to establish its efficacy and safety in skin of color.

 
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