| CTRI Number |
CTRI/2023/02/049617 [Registered on: 10/02/2023] Trial Registered Prospectively |
| Last Modified On: |
09/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [microneedling radiofrequency] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparative study of skin needling radiofrequency followed by injection of platelet rich plasma on left side of face with injectable platelet rich fibrin on right side of face in patients with acne scars. |
|
Scientific Title of Study
|
A split face comparative interventional study to evaluate efficacy of microneedling radiofrequency followed by platelet rich plasma vs microneedling radiofrequency followed by autologous injectable platelet rich fibrin in post acne scars. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Siri Vaidya |
| Designation |
Junior Resident |
| Affiliation |
JNMC,KAHER,BELGAUM |
| Address |
Department of Dermatology,JN Medical college, KAHER
Belgaum
KARNATAKA
599010
India |
| Phone |
09902253474 |
| Fax |
|
| Email |
siribvaidya14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijaya Sajjan |
| Designation |
Associate professor |
| Affiliation |
JNMC,KLE UNIVERSITY,BELGAUM |
| Address |
Department of Dermatology,JN Medical college, KAHER
Belgaum
KARNATAKA
599010
India |
| Phone |
9880503069 |
| Fax |
|
| Email |
vijaya_sajjan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijaya Sajjan |
| Designation |
Associate professor |
| Affiliation |
JNMC,KLE UNIVERSITY,BELGAUM |
| Address |
Department of Dermatology,JN Medical college, KAHER
Belgaum
KARNATAKA
599010
India |
| Phone |
9880503069 |
| Fax |
|
| Email |
vijaya_sajjan@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Patients attending dermatology OPD ,Dr Prabhakar Kore KLE HospitaL |
|
|
Primary Sponsor
|
| Name |
KAHER University |
| Address |
JN Medical College, Nehru Nagar,KAHER university, Belgaum |
| 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 |
| Dr Siri B Vaidya |
JN medical college,Dr Prabhakar Kore Hospital,Belagavi |
Dermatology OPD ,Room no 23
Belgaum
KARNATAKA |
9902253474
siribvaidya14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC institutional ethics committee |
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 |
| Intervention |
Microneedling Radiofrequency |
done every 4 weeks for 12 weeks |
| Comparator Agent |
Platelet rich plasma versus Injectable platelet rich fibrin |
Platelet rich plasma versus Injectable platelet rich fibrin.
Will be done once every 4 weeks for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients of above mentioned age group with fitzpatrick skin type 2-5.
Patients with grade 2-4 acne scars. |
|
| ExclusionCriteria |
| Details |
Patients with acne lesions, keloidal tendencies, on oral steroids/anti coagulation, history of bleeding disorders, with active viral/bacterial/fungal infection.
Pregnancy and Lactation.
Non consenting patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference of Goodman and Baron Acne scar grading score at baseline and at the end of 12 weeks |
Primary outcome will be assessed at the end of 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient assessment details are recorded and compared with physician assessment details. |
Assessment is done every 4 weeks for 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/02/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Majority of the acne scars occur on the face, thus impacting the quality of life. One novel modality of treatment is microneedling radiofrequency therapy also known or collagen induction therapy, has become an important treatment modality for acne scars. Initiation of collagen synthesis is achieved by causing minute injury to the dermis with the use of microneedles. The needles are so fine and thin that tissue damage is almost negligible. Electrical signals, triggers the cascade of the healing process, releasing growth signals to undifferentiated cells and resulting in new blood vessels formation and natural tissue remodeling which continues for 8 weeks to 1 year. This process is combined with platelet rich plasma and injectable platelet rich fibrin. They contain autologous growth factors, which act synergistically with growth factors induced by skin needling in order to enhance the wound-healing response. Additionally Injectable platelet rich fibrin has demonstrated the ability to release higher concentrations of various growth factors and induced higher fibroblast migration. Hence, this study is being performed to compare the effectiveness between platelet rich plasma and autologous injectable platelet rich fibrin |