| CTRI Number |
CTRI/2024/04/065382 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of oral tranexamic acid and topical triple combination cream in treatment of melasma |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy and safety of oral tranexamic acid with triple combination cream versus triple combination cream monotherapy in the treatment of Melasma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MOHAN H N |
| Designation |
Medical postgraduate, Dermatology |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of Dermatology, B block, Victoria hospital, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9845653469 |
| Fax |
|
| Email |
mohannaraharirao@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ASHA G S |
| Designation |
Professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of Dermatology, B block, Victoria hospital, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9448002120 |
| Fax |
|
| Email |
asha.ramesh62@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MOHAN H N |
| Designation |
Medical postgraduate, Dermatology |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of Dermatology, B block, Victoria hospital, Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9845653469 |
| Fax |
|
| Email |
mohannaraharirao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore medical college and research institute
Fort, KR road, Kalasipalya, Bengaluru, Karnataka, India
Pin code- 560002 |
|
|
Primary Sponsor
|
| Name |
MOHAN H N |
| Address |
Department of Dermatology, B block, Victoria hospital, Bangalore- 560002 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DR MOHAN H N |
Victoria hospital |
Department of dermatology
B block
Fort,K.R.Road
Bangalore-560002
Bangalore
KARNATAKA |
9845653469
mohannaraharirao@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L814||Other melanin hyperpigmentation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Oral Tranexamic acid and topical triple combination cream |
250mg oral tablet twice daily for 8 weeks in addition to topical triple combination cream once daily for 8 weeks |
| Intervention |
Triple combination cream |
Once daily topical application of cream for eight weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to give informed consent
2. Patients of either gender aged more than 18 years
3. Patients willing for follow up
4. Patients with clinically diagnosed melasma
|
|
| ExclusionCriteria |
| Details |
1. Patient not willing to give informed consent
2. Patient already on melasma treatment with topical therapy within 2 weeks.
3. Pregnant and lactating females.
4. History of coexisting endocrinopathies.
5. History of thrombosis, thromboembolic episodes and altered blood coagulation profile. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in melasma area and severity index |
Change in melasma area and severity index at 4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety and tolerability parameters of study medications |
At 4 weeks and 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
18/04/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Oral tranexamic acid is proved as a promising treatment option for melasma because of its demonstrated efficacy and limited side effect profile as a monotherapy and in combination with other modalities. Very few trials have been done regarding efficacy of oral tranexamic acid in Indian setting. so this study aims at comparing efficacy of combining oral tranexamic acid with triple combination cream versus triple combination cream alone in management of melasma. |