| CTRI Number |
CTRI/2025/07/090193 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
comparing the outcome of fat transplant versus platelet poor plasma biofiller in treating acne scars |
|
Scientific Title of Study
|
Autologous nanofat transplant versus platelet poor plasma biofiller in atrophic acne scars. A simultaneous split face comparative pilot study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Archana Reddy Purumandla |
| Designation |
post graduate resident |
| Affiliation |
institute of naval medicine |
| Address |
Room no 28, ward room mess, INHS Asvini, Colaba, Mumbai, Maharashtra, 400005.
department of dermatology, INHS Asvini, Colaba, Mumbai, Maharashtra, 400005.
Mumbai
MAHARASHTRA
400005
India |
| Phone |
8309033790 |
| Fax |
|
| Email |
archana23p@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jandhyala Sridhar |
| Designation |
Professor Dermatology |
| Affiliation |
institute of naval medicine |
| Address |
INHS Asvini, Colaba, Mumbai, Maharashtra, 400005.
department of dermatology, INHS Asvini, Colaba, Mumbai, Maharashtra, 400005.
Mumbai
MAHARASHTRA
400005
India |
| Phone |
8309033790 |
| Fax |
|
| Email |
asunilk22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Archana Reddy Purumandla |
| Designation |
post graduate resident |
| Affiliation |
institute of naval medicine |
| Address |
Room no 28, ward room mess, INHS Asvini, Colaba, Mumbai, Maharashtra, 400005.
department of dermatology, INHS Asvini, Colaba, Mumbai, Maharashtra, 400005.
Mumbai
MAHARASHTRA
400005
India |
| Phone |
8309033790 |
| Fax |
|
| Email |
archana23p@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of dermatology, INHS Asvini, colaba , mumbai , maharastra, INDIA-400005 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| 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 Jandhyala Sridhar |
department of dermatology |
institute of naval medicine, INHS Asvini, near R.C Church, colaba, mumbai, maharashtra, 400005
Mumbai
MAHARASHTRA |
8309033790
archana23p@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Naval Medicine |
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 |
nano fat transfer on one side of face |
harvesting sub cutaneous fat from abdomen site and transplanting to left side face |
| Intervention |
platelet poor plasma biofiller |
subdermal filling of platelet poor plasma on right side of face. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Grade II to Grade IV acne scars classified on the basis of Goodman qualitative classification.
Patient with equal Goodman quantitative and qualitative scores on both halves of the face.
No active acne lesions.
Patients with atrophic scars only
|
|
| ExclusionCriteria |
| Details |
Patients outside age criteria
Contraindication to surgical procedure
History of hypertrophic scarring or keloid
Allergic reaction to lignocaine and bupivacaine.
Active acne, folliculitis, herpes
Pregnancy
Systemic, autoimmune, bleeding disorders, patients on anticoagulant drugs and with unrealistic expectations.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Are PPP Bio gel and autologous nano fat transplant effective in treating atrophic acne scars?
2. Which modality has superior results
|
6 months from intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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)
|
14/07/2025 |
| 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="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
|
To compare the efficacy of autologous nano fat transplant and platelet poor plasma biofiller in atrophic acne scars. autologous fat would be harvested and processed and transplanted into left cheek of the patient. 10 ml venous blood would be extracted and plasma would be separated by centrifuge. separated plasma would be heated in a water bath so as to make in to a gel. it would be cooled down and injected into right cheek of the patient. |