| 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
|
|
|
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
|
|
|
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. |