| CTRI Number |
CTRI/2023/11/059775 [Registered on: 14/11/2023] Trial Registered Prospectively |
| Last Modified On: |
09/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare effectiveness of Fractional Co2 laser with Platelet rich plasma (PRP) Versus Microneedling with PRP in treatment of Acne scars |
|
Scientific Title of Study
|
A Split-face Comparative study on efficacy of Fractional CO2 Laser with PRP
vs. Microneedling with PRP in Treatment of Atrophic Acne Scars |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanoj |
| Designation |
Resident Dermatology |
| Affiliation |
Command Hospital Air Force Bangalore |
| Address |
Dept of Dermatology, Command Hospital Air Force Bangalore, Cambridge road, Bangalore
Bangalore
KARNATAKA
560007
India |
| Phone |
7051891307 |
| Fax |
|
| Email |
sanojpkafmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Debdeep Mitra |
| Designation |
Prof |
| Affiliation |
Command Hospital Air Force Bangalore |
| Address |
Dept of Dermatology, Command Hospital Air Force Bangalore, Cambridge road, Bangalore
Bangalore
KARNATAKA
560007
India |
| Phone |
7051891307 |
| Fax |
|
| Email |
debdeep5000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanoj |
| Designation |
Resident Dermatology |
| Affiliation |
Command Hospital Air Force Bangalore |
| Address |
Dept of Dermatology, Command Hospital Air Force Bangalore, Cambridge road, Bangalore
Bangalore
KARNATAKA
560007
India |
| Phone |
7051891307 |
| Fax |
|
| Email |
sanojpkafmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Command Hospital Air Force Bangalore, cambridge road, Bangalore, Karnataka, 560007 |
|
|
Primary Sponsor
|
| Name |
Command Hospital Air Force Bangalore |
| Address |
Command Hospital Air Force Bangalore, Cambridge Rd, Bangalore, Karnataka, 560007 |
| Type of Sponsor |
Government 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 |
| Dr Sanoj |
Command Hospital Air Force Bangalore |
Room No.6, Dept of Dermatology, Command Hospital Air Force Bangalore, Karnataka, 560007
Bangalore
KARNATAKA |
7051891307
sanojpkafmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| EC Command Hospital (Air Force), Bangalore |
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 with Platelet rich plasma (PRP) |
This is a split face study in which the patients will be randomised to receive fractional CO2 laser over one side of face, while the other side will be treated with Microneedling. Both procedure will be followed by PRP injections and massaging the PRP drops over treated areas. Total 4 such treatment sessions will be given at an interval of 4 weeks. Final follow up will be done 04 weeks after the last session. The duration of study will be 18 months. |
| Intervention |
Microneedling with Platelet rich Plasma (PRP) |
This is a split face study in which the patients will be randomized to receive fractional CO2 laser over one side of face, while the other side will be treated with Microneedling. Both procedure will be followed by PRP injections and massaging the PRP drops over treated areas. Total 4 such treatment sessions will be given at an interval of 4 weeks. Final follow up will be done 04 weeks after the last session.The duration of the study will be 18 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
(i) Patients above the age of 18 years.
(ii) Patients with acne scars with > 2 points on Goodman and baron’s quantitative global
acne scarring grading system over both side of face.
(iii) Patients who are willing to undergo the evaluation system and able to comply with all
follow-up requirements. |
|
| ExclusionCriteria |
| Details |
(i) Patients with active acne or any local site infection.
(ii) Patients with acne scars with ≤ 2 points on Goodman and baron’s quantitative global
acne scarring grading system over any side of face.
(iii) Patients below 18years and above 60 years
(iv) Patients not willing for the procedure.
(v) Patients having keloid or keloidal tendency
(vi) Patients who have taken isotretinoin within 06 months or have undergone laser
treatment or Microneedling over face within previous 01 year.
(vii) Any serious medical condition including bleeding diathesis, platelet disorders or in
immunocompromised state.
(viii) Patients with past history of herpes infection.
(ix) Pregnant and lactating mothers.
(x) Patients with unrealistic expectations. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess which modality is more efficacious in the treatment of Atrophic Acne scars i.e. Fractional CO2 laser with PRP or Microneedling with PRP |
After completion of study i.e. one and half years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) To asses the effectiveness of Fractional CO2 laser with PRP for treatment of Atrophic Acne scars.
b) To asses the effectiveness of Microneedling with PRP for treatment of Atrophic Acne scars.
c) To asses the side-effect profile & safety of Fractional CO2 laser with PRP & Microneedling with PRP therapy. |
After completion of study i.e. one & half years |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
21/11/2023 |
| 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) |
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sanojpkafmc@gmail.com].
- For how long will this data be available start date provided 15-04-2025 and end date provided 15-01-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is done to compare the efficacy of Fractional CO2 laser with PRP versus Microneedling with PRP for treatment of atrophic acne scars along with efficacy of the individual intervention as separate entity and their adverse effects. Acne scar treatment remains one of the greatest challenges that dermatologists face on daily basis. Fractional CO2 laser and Dermaroller has shown good results with minimal complication. PRP modality in Acne scars treatment is an emerging area and has shown good results both independently and as an adjunct with other modalities. There is paucity of study comparing Fractional CO2 laser and Microneedling with PRP as adjunct. Therefore this study has compared the efficacy of fractional CO2 laser with PRP versus Microneedling with PRP for treatment of acne scars. |