| CTRI Number |
CTRI/2024/07/071158 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare the effect of microneedling with 2 medications, Tranexamic acid and Vitamin C, for reducing the skin pigmentation in patients with melasma. |
|
Scientific Title of Study
|
A split-face comparative study
assessing the efficacy of microneedling with Tranexamic acid vs microneedling
with Vitamin C in the treatment of melasma. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Varsha Reddy Parupati |
| Designation |
Postgraduate |
| Affiliation |
Sri Ramachandra Institute for Higher Education and Research |
| Address |
Department of Dermatology , Venereology and Leprosy, Sri Ramachandra Medical College and Research Institute, No.1, Ramachandra Nagar, Porur , Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9246568134 |
| Fax |
|
| Email |
varsha.reddy3993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Murugan Sundaram |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Institute for Higher Education and Research |
| Address |
Department of Dermatology, Venereology and Leprosy , Sri Ramachandra Medical College and Research Institute, No.1, Ramachandra Nagar, Porur , Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9790954956 |
| Fax |
|
| Email |
murug1972@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Varsha Reddy Parupati |
| Designation |
Postgraduate |
| Affiliation |
Sri Ramachandra Institute for Higher Education and Research |
| Address |
Department of Dermatology, Venereology and Leprosy , Sri Ramachandra Medical College and Research Institute, No.1, Ramachandra Nagar, Porur , Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9246568134 |
| Fax |
|
| Email |
varsha.reddy3993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research, No.1 ,Ramachandra nagar, Porur, Chennai, Tamil Nadu ,India , 600116. |
|
|
Primary Sponsor
|
| Name |
Varsha Reddy Parupati |
| Address |
Hostel number 5, Sri Ramachandra Medical College and Research Institute , No.1, Ramachandra Nagar, Porur, Chennai, 600116. |
| Type of Sponsor |
Other [Individual ] |
|
|
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 |
| Varsha Reddy Parupati |
Sri Ramachandra Institute of Higher Education and Research |
Department of Dermatology, Venereology and Leprosy , Room number 18, G block, No.1 Ramachandra Nagar, Porur, Chennai - 600 116
Chennai
TAMIL NADU |
9246568134
varsha.reddy3993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Ethics Committee , Sri Ramachandra Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L811||Chloasma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Microneedling with Tranexamic acid and Microneedling with Vitamin C in a split-face manner |
Microneedling with Tranexamic acid over the right side of the face and Microneedling with Vitamin C over the left side of the face, done in 4 sessions, 2 weeks apart. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
Females aged 18 years and above with Melasma over bilateral sides of the face. |
|
| ExclusionCriteria |
| Details |
Male gender.
Pregnant women, breastfeeding mothers.
History of use of oral contraceptive pills or hormone replacement therapy in the past 12 months or during the study.
History of coagulation disorders and thrombotic problems.
History of use of topical depigmenting agents within the last 60 days of the study.
Presence of active infection over the face.
Presence of keloidal tendency. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in MASI score |
2, 4, 6 , 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction |
2 , 4, 6 ,8 weeks |
|
|
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 3 |
|
Date of First Enrollment (India)
|
02/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
30 patients who fit the inclusion and exclusion criteria will be enrolled in the study after obtaining informed consent. A detailed history taking, examination, clinical photographs and MASI ( Melasma Area Severity Index ) score calculation will be done for all the patients prior to starting the intervention. Intervention will be done at 0,2,4, and 6 weeks and patient will be assessed at 2,4,6, and 8 weeks. Initially, patients face will be cleansed and topical anaesthetic (PRILOX cream ) will be applied for 45 minutes. Intervention will be in the form of application of Tranexamic acid ( 50mg in 2 ml ) over the right side of the face using sterile gauze, and 20% vitamin C serum ( 2ml ) over the left side of the face, following which1.5mm depth and 0.25mm width derma roller will be used to perform micro needling procedure on both sides. Patient will be observed for 30minutes post procedure for any side effects. Cumulative assessment of MASI score will be done at 8 weeks. |