| CTRI Number |
CTRI/2019/07/020340 [Registered on: 23/07/2019] Trial Registered Prospectively |
| Last Modified On: |
21/07/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Oral tranexamic acid in the treatment of moderate to severe melasma. |
|
Scientific Title of Study
|
A randomized, open label study of two different dosage regimens of oral tranexamic acid in the treatment of moderate to severe melasma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muthu Sendhil Kumaran |
| Designation |
Additional Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Faculty offices, F block, Nehru Hospital, PGIMER
Sector 12 Sector 12 Chandigarh CHANDIGARH 160012 India |
| Phone |
8872004023 |
| Fax |
|
| Email |
drsen_2000@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Muthu Sendhil Kumaran |
| Designation |
Additional Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Faculty offices, F block, Nehru Hospital, PGIMER
Sector 12 Sector 12
CHANDIGARH 160012 India |
| Phone |
8872004023 |
| Fax |
|
| Email |
drsen_2000@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Muthu Sendhil Kumaran |
| Designation |
Additional Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Faculty offices, F block, Nehru Hospital, PGIMER
Sector 12 Sector 12
CHANDIGARH 160012 India |
| Phone |
8872004023 |
| Fax |
|
| Email |
drsen_2000@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Faculty Offices, F block, Nehru Hospital, 4th floor, PGIMER Chandigarh |
|
|
Primary Sponsor
|
| Name |
PGIMER Chandigarh |
| Address |
C/O Dr. Muthu Sendhil Kumaran, Faculty Offices, F bLOCK, 4th Floor, Nehru Hospital, PGIMER |
| Type of Sponsor |
Government medical college |
|
|
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 |
| M Sendhil Kumaran |
PGIMER Chandigarh |
Skin OPD, 5TH Level, C Block, New OPD Block, PGIMER, Chandigarh Chandigarh CHANDIGARH |
8872004023
drsen_2000@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral tranexemic acid |
Oral tranexemic acid 250 mg twice a day for 3 months |
| Comparator Agent |
Oral tranexemic acid |
Oral tranexemic acid 500 mg twice a day for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Female and male patients aged more than 18 years with moderate to severe melasma (Moderate melasma will be defined as melasma patients with mMASI score of 5.8 to 7.9 and severe melasma as those with mMASI ≥ 8 based on defined ranges for melasma severity.46 |
|
| ExclusionCriteria |
| Details |
1. Known drug hypersensitivity to TXA.
2. Patients on medications for cardiovascular, gastrointestinal, hepatic, renal, disorders.
3. Pregnant or lactating mothers
4. Patients having history of hypercoagulable disorders or history of thrombotic episodes like deep vein thrombosis, pulmonary embolism, cerebral vein thrombosis.
5. Patients taking oral contraceptive pills.
 
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The primary objective is to evaluate and compare the efficacy of two different dosing regimens of TXA, that is, 250 mg twice daily versus 500 mg twice daily, using the mMASI score. The proportion of patients achieving mMASI 75 assesses the efficacy.
|
Baseline, monthly for 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Proportion of patients achieving mMASI 90
2. To assess the dose of TXA that acts faster (time to achieve mMASI 75) and prevents relapse while on maintenance therapy.
3. Change in MELASQOL index over the six month study period.
4. Duration of treatment
5. Adverse events, if any, due to TXA
|
baseline, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
01/09/2020 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Melasma
is a common, acquired disorder of hyperpigmentation affecting millions of
people worldwide. It causes tremendous impact on the self esteem and quality of
life of the affected people, especially females. While various topical agents
have so far been the mainstay of treatment of melasma, they are plagued by side
effects as well relapse and recurrences omce they are stopped. Oral tranexemic
acid (TXA) is the latest tool in the armamentarium of melasma treatment. It has
so far been used in various forms including oral, topical and injectable with
variable but promising results. However, the dosing
of TXA in melasma has been a cause of persistent speculation and this puzzle is
what our study aims to shed some light on. Doses of TXA used for melasma in
studies to date have ranged from 500 to 1,500mg daily.45 A typical
dose is 250 mg twice daily. Treatment is usually continued for 8 to 12 weeks.45
This is in contrast to menorrhagia for which the dose is 3.9 to 4 g daily for
up to 5 days per month.34 However, there is still no consensus to
guide the dose and duration of therapy. There is also not much clarity on the
risk of relapse after stopping oral TXA and if maintenance treatment is
required and if so, if the duration of maintenance regimen differes with
different dosages of TXA. Studies have documented safe useof TXA for
menorrhagia over the years with only minor side effects like nasal and sinus
discomfort, back pain, musculoskeletal pain, oligomenorrhea, and abdominal
cramps, with no evidence of ocular toxicity.22, 34, 35 Hence, at the dosages currently employed and based on available data, it seems unlikely
that TXA would increase risk of thrombotic complications, more so in the
indications for which it is used in dermatology.
The present study is designed as a randomized, open
label study in which 50 patients suffering from moderate to severe melasma
according to the mMASI scores will be recruited and be divided into two arms to
receive oral tranexemic acid at a dose of 250 mg twice a day or 500 mg twice a
day for 12 weeks along with a sunscreen of SPF 30+. The
primary objective is to evaluate and compare the efficacy of the two different
dosing regimens of TXA, that is, 250 mg twice daily versus 500 mg twice daily, using
the mMASI score. The proportion of
patients achieving mMASI 75 will be used as the proxy measure to assess the
efficacy. The secondary aims will include assessing the MELASQOL score of the
patients at baseline and the end of treatment to have an objective analysis of
the impairment of quality of life caused by melasma, apart from noting any adverse
effects, if any.
|