| CTRI Number |
CTRI/2018/05/014062 [Registered on: 23/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
20/05/2018 |
| 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 study to compare two treatment options for melasma. |
|
Scientific Title of Study
|
A double arm RCT comparing the efficacy of intralesional Tranexamic acid with standard topical kligman’s regimen in patients with facial melasma. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pawan Gupta |
| Designation |
Resident Doctor |
| Affiliation |
K.J Somaiya medical college and research center |
| Address |
Department of Dermatology, OPD no.26, 6th floor, K.J Somaiya medical college and hospital, Everard Nagar, Eastern Express Hihgway, Sion East, Mumbai 400022.
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
8770246306 |
| Fax |
|
| Email |
pawanguptag@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shital Poojary |
| Designation |
Professor and Head |
| Affiliation |
K.J Somaiya medical college and research center |
| Address |
Department of Dermatology, OPD no.26, 6th floor, K.J Somaiya medical college and hospital, Everard Nagar, Eastern Express Hihgway, Sion East, Mumbai.
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
9820601511 |
| Fax |
|
| Email |
spoojary2004@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pawan Gupta |
| Designation |
Resident Doctor |
| Affiliation |
K.J Somaiya medical college and research center |
| Address |
Department of Dermatology, OPD no.26, 6th floor, K.J Somaiya medical college and hospital, Everard Nagar, Eastern Express Hihgway, Sion East, Mumbai.
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
8770246306 |
| Fax |
|
| Email |
pawanguptag@gmail.com |
|
|
Source of Monetary or Material Support
|
| K.J Somaiya medical college and research center, Mumbai |
|
|
Primary Sponsor
|
| Name |
Pawan Gupta |
| Address |
K.J Somaiya medical college and hospital, Everard Nagar, Eastern Express Hihgway, Sion East, Mumbai 400022. |
| Type of Sponsor |
Other [prinicipal 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 |
| Pawan Gupta |
K.J Somaiya hospital |
Department of Ddermatology, opd no. 26, 6th floor, K.J Somaiya medical college and hospital, Everard Nagar, Eastern Express Hihgway, Sion East, Mumbai 400022.
Mumbai (Suburban)
MAHARASHTRA |
8770246306
pawanguptag@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K.J. SOMAIYA MEDICAL COLLEGE & HOSPITAL, MUMBAI INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
facial melasma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Tranexamic acid |
Intradermal injections of Tranexamic acid 4 mg/mL. Injections of about 0.05mL at 1 cm interval every 2 weeks for 12 weeks or till complete clearance. |
| Comparator Agent |
Kligman’s therapy |
Topical Kligman’s therapy (0.05% tretinoin, 4% hydroquinone, 0.01% flucinolone acetonide) for 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All consenting male and female patients diagnosed clinically with melasma |
|
| ExclusionCriteria |
| Details |
a) Pregnancy, lactation and females taking HRT/OCP’s
b) Any severe chronic medical illness,
c) Bleeding disorders or concomitant use of anticoagulants
d) Any medical treatment for melasma within 1 month of entry,
e) Hypersensitivity to TXA
f) Abnormal bleeding time, clotting time or platelet count
g) Refusal to allow photographs and Failure to finish the whole period of study would be excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in modified melasma area and severity index (mMASI). |
4 weeks, 8 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| physician’s global assessment and patient global assessment scales, and safety assessment |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/09/2017 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Treatment of melasma is a real challenge due to its frequent recurrence, persistence and aggravation during or after the treatment. Hence, there has always been a need to evaluate for safe, efficacious and new therapeutic options at an affordable price to the patients without affecting their compliance to treatment. No single treatment has been proven to be the most efficacious. In the field of dermatology, tranexamic acid (TXA) has been used as an oral agent in melasma patients for its whitening effects. However, no studies on clinical efficacy and safety of intralesional TXA for treatment of melasma patients have been reported from India till date. This is a parallel group open- label randomized controlled trial in dermatology OPD of our hospital consisting of 60 patients of facial melasma who would randomly be divided into Group A (intralesional TXA) and Group B ( topical Kligman’s) therapy for 3 months. Modified MASI scores would be calculated at week 0, 4, 8, 12 and statistically analysed. Therefore, we plan this study to evaluate the efficacy and safety of intralesional TXA (at interval of 2 weeks) as treatment of melasma. |