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
|
|
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
|
|
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. |