| CTRI Number |
CTRI/2024/01/061520 [Registered on: 16/01/2024] Trial Registered Prospectively |
| Last Modified On: |
27/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Procedure-Fractional CO2 laser and Injectable platelet rich plasma ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of fractional CO2 laser on one side of the face and combination of Fractional CO2 laser with Injectable Platelet Rich plasma on the other side of the face for the treatment of acne scars |
|
Scientific Title of Study
|
Comparative study of fractional CO2 laser monotherapy and fractional CO2 laser with injectable Platelet rich plasma in acne scars in a tertiary care centre ,Chengalpattu-A double blinded Randomised control trial |
| 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 |
1 st year Postgraduate - Dermatology |
| Affiliation |
The Tamilnadu Dr MGR medical university |
| Address |
Room number 29, Dermatology Opd, Karpaga vinayaga institute of medical sciences and research centre
Chennai
TAMIL NADU
600037
India |
| Phone |
7010236118 |
| Fax |
|
| Email |
abinayaaravikumar3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dhanalakshmi |
| Designation |
HOD ,Department of Dermatology |
| Affiliation |
The Tamilnadu Dr MGR medical university |
| Address |
Room number 29,Dermatology opd,karpaga vinayaga institute of medical sciences and research centre
Chennai
TAMIL NADU
600037
India |
| Phone |
9566120848 |
| Fax |
|
| Email |
drdhanuk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhanalakshmi |
| Designation |
HOD , Department of Dermatology |
| Affiliation |
The Tamilnadu Dr. M.G.R medical university |
| Address |
Room number 29,Department of dermatology,KIMS and RC
Chennai
TAMIL NADU
603308
India |
| Phone |
9566120848 |
| Fax |
|
| Email |
drdhanuk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karpaga vinayaka institute of medical sciences and research centre,GST road ,chinnakolambakkam,Madhurandhagam,Tamilnadu-603308 |
|
|
Primary Sponsor
|
| Name |
Karpaga vinayaka institute of medical sciences and research institute |
| Address |
G.S.T road , chinna kolambakkam, palayanoor (P.O), Kancheepuram-603308 |
| 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 |
| Abinayaa R M |
Karpaga vinayaka institute of medical sciences and research institute |
Room number 29,Department of Dermatology
Chennai
TAMIL NADU |
7010236118
abinayaaravikumar3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of karpaga vinayaga institute of medical sciences and research centre (HUMAN STUDIES) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L905||Scar conditions and fibrosis of skin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fractional CO2 laser |
Fractional co2 laser
Power- 20 W
Distance-0.8mm
Duration- 0.8 ms
Frequency- every 4 wks for 3 months on one side of the face
|
| Intervention |
Fractional CO2 laser and injectable Platelet Rich plasma |
Fractional CO2 laser
Power- 20 W
Duration- 0.8ms
Frequency- every 4 weeks for 3 months
Platelet Rich plasma
Dose - 0.1 ml /cm2 on one side of the face
Frequency- every 4 weeks for 3 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients with acne scar >18 yrs with grade 2 to 4, willing to give informed consent .
|
|
| ExclusionCriteria |
| Details |
1.Those with active inflammation
2. Those who are predisposed to keloid
3.Those with collagen vascular diseases
4. Those with active herpes infection
5.Those not willing to take part in the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Facial acne scars improvement assesed by Goodman and boron’s quantitative and qualitative acne scar grading scale for each side of the face separately
|
At 4wks,8 wks,12 wks and 20 wks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Acne scar improvement graded based on Goodman & boron’s quantitative & qualitative scar grading scale |
At 4weeks,8 weeks,12weeks & 20 weeks |
|
|
Target Sample Size
|
Total Sample Size="59"
Sample Size from India="59"
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)
|
01/02/2024 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
Modification(s)
|
Atrophic acne scars are further subclassified into ice pick(60-70%) boxcar(20-30%), and rolling scars(15-25 % ) . Acne scars have significant impact over the patient’s social and psychological aspects of life. There are various treatment options available for acne scars such as chemical peels, dermabration, ablative and non ablative lasers, autologous fat grafting ,radio frequency, punch excision ,punch elevation, punch replacement grafting ,the delay in which leads to redundent scaring making it much more challenging to treat.Although there are various treatments options for treating acne scars ,single modality doesn’t give effective results.
Until now in accordance with the previous studies, there are no definitive treatments to revert the skin to nearly normal . so I would like to combine fractional co2 laser (standard method) with Platelet Rich Plasma in a split face study in patients with acne scars between 18 To 40 yrs by randomised control trial .
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