| CTRI Number |
CTRI/2023/05/052649 [Registered on: 15/05/2023] Trial Registered Prospectively |
| Last Modified On: |
17/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [prospective interventional study] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of microneedling versus intradermal injection using tranexamic acid in the treatment of Melasma |
|
Scientific Title of Study
|
Efficacy of tranexamic acid microneedling versus intradermal injection of tranexamic acid in the treatment of Melasma-A Randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SRIJHA M |
| Designation |
Post graduate in MD DVL |
| Affiliation |
Aarupadai veedu medical college,Pondicherry |
| Address |
AARUPADAI VEEDU MEDICAL COLLEGE,KIRUMAMPAKKAM,PONDICHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9965929696 |
| Fax |
|
| Email |
srijhafeb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Damayandhi K |
| Designation |
Associate professor in DVL department |
| Affiliation |
Aarupadai veedu medical college,Pondicherry |
| Address |
DEPARTMENT OF DERMATOLOGY,AARUPADAI VEEDU MEDICAL COLLEGE,KIRUMAMPAKKAM,PONDICHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9488511884 |
| Fax |
|
| Email |
deepakaliyaperumal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SRIJHA M |
| Designation |
Post graduate in MD DVL |
| Affiliation |
Aarupadai veedu medical college,Pondicherry |
| Address |
AARUPADAI VEEDU MEDICAL COLLEGE,KIRUMAMPAKKAM,PONDICHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9965929696 |
| Fax |
|
| Email |
srijhafeb@gmail.com |
|
|
Source of Monetary or Material Support
|
| AARUPADAI VEEDU MEDICAL COLLEGE,PONDICHERRY |
|
|
Primary Sponsor
|
| Name |
AARUPADAI VEEDU MEDICAL COLLEGE,PONDICHERRY |
| Address |
AARUPADAI VEEDU MEDICAL COLLEGE,KIRUMAMPAKKAM,PONDICHERRY,607402 |
| Type of Sponsor |
Private 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 |
| SRIJHA M |
Aarupadai Veedu medical college, |
Department of Dermatology, Venerology and Leprology,
Block C
Kirumampakkam,pondicherry,607402
Pondicherry
PONDICHERRY |
9965929696
srijhafeb@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AVMC INSTITUITIONAL HUMAN ETHICAL COMMITEE |
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 |
| Intervention |
Microneedling and Intradermal injection |
Microneedling and Intradermal injection at monthly intervals 0,4,8,12 weeks |
| Comparator Agent |
Tranexamic acid micro needling and intradermal injection of tranexamic acid |
Tranexamic acid micro needling and intradermal injection of tranexamic acid at 0,4,8 and 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with Epidermal/Dermal /Mixed type of melasma
2.Patients willing for consent, study and follow up
|
|
| ExclusionCriteria |
| Details |
1.Pregnancy
2,Patients on hormone replacement therapy
3.Patients on contraceptive pills
4.Patients on anticoagulants
5.Allergic to drugs under the study
6.Non compliant patients
7.Patients with keloidal or Hypertrophic scar tendency
8.Patients with the history of depigmenting treatment in the past 1 month
9.Moderate to severe acne vulgaris on face
10.History of Herpes infections, Warts
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified Melasma Area and Severity Index (Modified MASI) score: Primary outcome to assess treatment response. |
At baseline,4weeks, 8weeks & 12 weeks and followed up for further 2 months at monthly intervals.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient global assessment scale and |
At baseline, 4weeks, 8weeks & 12 weeks and followed up for further 2 months at monthly intervals.
|
| Clinical improvement assessed based on photographic document |
At baseline, 4weeks, 8weeks & 12 weeks and followed up for further 2 months at monthly intervals.
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/05/2023 |
| Date of Study Completion (India) |
15/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/04/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Melasma is a complicated disorder whose management is very resistant to treatment and also affects the quality of life adversely.Incidence among Indians are 10%.1st line treatment includes topical medications followed by chemical peels and lasers.Despite numerous therapies treatment remains difficult.So there is a need for study of novel agents like Tranexamic acid in the treatment of Melasma.So this study attempts to compare the efficacy of Tranexamic acid micro needling and Intradermal injection in the treatment of Melasma among the Outpatients of the department of dermatology. |