| CTRI Number |
CTRI/2024/10/075226 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Assessment of Microdermabrasion as a method to enhance efficacy of topical anaesthesia
|
|
Scientific Title of Study
|
Assessment of Microdermabrasion as a method to enhance efficacy of topical anaesthesia - A split face study in a tertiary care Setting, chengalpattu
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abinayaa R M |
| Designation |
Postgraduate DVL |
| Affiliation |
The Tamilnadu Dr.M.G.R.Medical university |
| Address |
Room number 29,Department of Dermatology,karpaga vinayaga institute of medical sciences and research centre,GST road,chinna kolambakkam,kanchipuram
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
7010236118 |
| Fax |
|
| Email |
abinayaaravikumar3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dhanalakshmi |
| Designation |
Professor and HOD DVL |
| Affiliation |
The Tamilnadu Dr.M.G.R.university medical university |
| Address |
Room number 29, Department of Dermatology,karpaga vinayaga institute of medical sciences and research centre,GST road,chinna kolambakkam,kanchipuram
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9566120848 |
| Fax |
|
| Email |
drdhanuk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abinayaa R M |
| Designation |
Postgraduate DVL |
| Affiliation |
The Tamilnadu Dr.M.G.R medical university |
| Address |
Room number 29,Department of Dermatology,karpaga vinayaga institute of medical sciences and research centre,GST road,chinna kolambakkam,kanchipuram
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
7010236118 |
| Fax |
|
| Email |
abinayaaravikumar3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karpaga vinayaga institute of medical sciences and research centre,GST road, chinna kolambakkam, madhuranthagam, Kanchipuram,TN-603308 |
| Patient |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
N/A |
| Type of Sponsor |
Other [Nil ] |
|
|
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 Abinayaa |
karpaga vinayaga institute of medical sciences and research centre |
Room number 29,Department of Dermatology,P.O,GST road ,chinna kolambakkam,palayanoor,madhuranthagam
Kancheepuram
TAMIL NADU |
7010236118
abinayaaravikumar3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karpaga vinayaga institute of medical sciences and research centre Institutional Ethics committee ( human studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L812||Freckles, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Microdermabrasion before the application of topical anaesthesia for procedures |
Microdermabrasion will be done to flat skin lesions on one side of the face . Then topical anaesthesia will be applied to the entire face . VAS score will be calculated every 15 minutes at 15,30,45,60 minutes and lesions will be removed based on the pain score in a single session.Duration of the study-6 months |
| Comparator Agent |
Microdermabrasion before the application of topical anaesthesia on one side of the face |
Analgesia onset time will be compared on both sides of face |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients more than 18 yrs
2. Those with indications for aesthetic procedures that require topical anaesthetic
3. Those who are willing to give informed consent
4.Those with minimum of 4 flat skin lesions on each side of cheek like DPN,freckles,acne scar
|
|
| ExclusionCriteria |
| Details |
1.Those with active inflammation
2. Those who are predisposed to keloid
3.Those with neuropathic disorders who cannot sense pain on face
4.Those with active cutaneous infections
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Analgesia onset time will be assesed at 15,30 ,45,60 minutes |
At 15,30,45,60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total duration of the procedure on each side of face |
VAS score at 15,30,45,60 minutes |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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="0"
Months="6"
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
|
My study is aimed at evaluating if Microdermabrasion prior to application of topical anaesthetic can shorten the duration of topical anaesthetic application and reach adequate depth required for aesthetic procedures.This approach helps patients achieve analgesia in a very short time compared to the conventional method , thereby reducing the downtime of the opd procedure |