| CTRI Number |
CTRI/2025/12/098631 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Procedure based] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two combination treatments for acne scars- subcision with microneedling and subcision with Injectable Platelet rich fibrin. |
|
Scientific Title of Study
|
Comparative evaluation of Subcision followed by Microneedling versus Subcision
followed by Injectable Platelet-Rich Fibrin in the management 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 |
Heeral Vadera |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Sawangi, Meghe, Wardha |
| Address |
Department of Dermatology, Venereology and Leprosy, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha
Wardha
MAHARASHTRA
442005
India |
| Phone |
9130184884 |
| Fax |
|
| Email |
heeral.v123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhushan Madke |
| Designation |
HOD and Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Sawangi, Meghe, Wardha |
| Address |
Department of Dermatology, Venereology and Leprosy, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha
Wardha
MAHARASHTRA
442005
India |
| Phone |
7066887353 |
| Fax |
|
| Email |
drbhushan81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Heeral Vadera |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Sawangi, Meghe, Wardha |
| Address |
Department of Dermatology, Venereology and Leprosy, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha
Wardha
MAHARASHTRA
442005
India |
| Phone |
9130184884 |
| Fax |
|
| Email |
heeral.v123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha |
|
|
Primary Sponsor
|
| Name |
Heeral Vadera |
| Address |
Department of Dermatology, Venereology and Leprosy, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha, Maharashtra 442107, India |
| 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 Heeral Vadera |
Jawaharlal Nehru Medical College, Sawangi, Meghe, Wardha |
Department of Dermatology, Venereology and Leprosy, Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha
Wardha
MAHARASHTRA |
09130184884
heeral.v123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research |
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 |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Subcision and Injectable Platelet rich fibrin for acne scars |
Subcision technique:
The face will be prepared and draped in sterile fashion.
Local anaesthesia will be administered using tumescent technique.
An entry point will be made near the tragus of ear from which a Taylor’s Liberator will be inserted sub dermally just distal to each target region and slowly advanced parallel to dermis.
Rapid, repetitive advancement and retraction of the needle under the scarred area will be subsequently performed to abrade the underside of the dermis while dislodging any fibrous attachments to the deeper tissues.
This action will be repeated in a fan like pattern to cover the entire region.
Pressure dressing will be placed over treated area.
Injectable Platelet-Rich Fibrin technique: A.Preparation of Injectable platelet rich fibrin(iPRF): Under all aseptic precautions, 30 mL of whole venous blood will be withdrawn from antecubital vein and is collected into two 15 mL sterile conical bottom centrifuge plastic tubes. No anticoagulant is added to the tubes. The tubes will then be centrifuged at 800 rpm for 4 minutes. The tubes will be removed and the upper yellow-orange-coloured liquid will be obtained as Injectable platelet rich fibrin. The product obtained will be filled in insulin syringes and will be injected into treatment areas as soon as possible. B.Technique for iPRF: Face will be prepared under aseptic conditions. A topical anaesthetic cream will be applied over the face for 45 minutes before the procedure. 0.1 ml of PRF will be injected intradermally into each atrophic scar with 1.5-2 cm interval using insulin syringe followed by gentle massaging of the area. |
| Intervention |
Subcision and Microneedling for acne scars |
Subcision technique:
The face will be prepared and draped in sterile fashion.
Local anaesthesia will be administered using tumescent technique.
An entry point will be made near the tragus of ear from which a Taylor’s Liberator will be inserted sub dermally just distal to each target region and slowly advanced parallel to dermis.
Rapid, repetitive advancement and retraction of the needle under the scarred area will be subsequently performed to abrade the underside of the dermis while dislodging any fibrous attachments to the deeper tissues.
This action will be repeated in a fan like pattern to cover the entire region.
Pressure dressing will be placed over treated area.
Microneedling technique:
Face will be cleaned and prepared under aseptic conditions.
Topical anaesthetic cream will be applied over the treatment area for 30-40 minutes.
Dermapen 4 will be set up and used for the procedure.
Hyla active (Hyaluronic acid) will be applied on the treatment area surface to facilitate the gliding action of the Dermapen and to prevent untoward injury to the overlying epidermis.
The treatment technique will involve a combination of horizontal, vertical, and oblique device passes over the treatment areas, repeating approximately 3 times or until fine pinpoint bleeding is observed.
Depth of needling will be based on the area:
For forehead: 0.4 -0.6 mm
For cheeks: 0.7-1mm
For chin and upper lips: 0.2-0.4 mm
When treating deep scars, a rocking or stamping technique will be used to increase density of channels created by microneedling.
Achievement of pin-point bleeding will mark the clinical end point of the procedure.
Sterile gauze will be used to clean the face.
Patient will be advised to maintain strict sun protection and will be prescribed sunscreen with SPF 30 or more and a moisturiser.
Patient will be called for next sitting after one month of procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients above 18 years of age.
2. Patients who have given written consent before treatment is commenced.
3. Patients with atrophic acne scars (rolling, boxcar, or ice pick).
4. Patients who are willing to comply with treatment protocols and follow-up
visits |
|
| ExclusionCriteria |
| Details |
1. Patients with history of hypertrophic scars and keloid.
2. Patients with active acne lesions.
3. Patients with contraindications to Subcision, Microneedling, or iPRF (e.g.,
bleeding disorders, coagulation disorders, any active skin infections like
herpes, etc.).
4. Patients with unrealistic expectations.
5. Seropositivity for HIV, Hepatitis B and Hepatitis C |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess scar improvement using Echelle d’Evaluation Clinique des Cicatrices d’acne (ECCA) score |
At the end of study (After 2 years) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/12/2025 |
| 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="2"
Months="0"
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
|
Research question- Is Subcision followed by microneedling more effective than Subcision followed by injectable platelet-rich fibrin (iPRF) for treatment of atrophic acne scars?
Study Design- This will be a two-year prospective interventional study conducted in the Department of Dermatology, Venereology and Leprosy of AVBRH, Sawangi (Meghe).
Study Setting- Patients having atrophic acne scars coming to Department of Dermatology, Venerology and Leprosy, Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha.
Study Population- Patients having atrophic acne scarring, including both genders and >18 years of age, coming to the Dermatology, Venereology and Leprosy (DVL) department at Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha will be included in the study.
Sample size- 40
Methodology- A total of 40
patients attending the outpatient department of Dermatology, Venerology and Leprosy, AVBRHfor the management of acne scars will
be enrolled for this study. All enrolled patients will be informed about
the procedure, including potential side effects, and written informed consent
will be obtained prior to participation. Detailed history and thorough
dermatological, physical and systemic examination will be conducted. They will
be graded according to the ECCA scoring. Patients will then be randomised into two groups
based on computer-generated randomisation. Group A will be treated with
Subcision followed by Microneedling and Group B will be treated with Subcision
followed by Injectable Platelet rich fibrin. Subcision will be done in the
first session followed by either Microneedling or Injectable
Platelet-Rich Fibrin (iPRF)
in the subsequent session. Clinical photographs of front, left and right
profile of face will be taken and ECCA scoring will be done with the patient’s informed
consent at every visit |