| CTRI Number |
CTRI/2021/03/032315 [Registered on: 25/03/2021] Trial Registered Prospectively |
| Last Modified On: |
26/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Microneedling with Platelet Rich Fibrin in post Acne scars |
|
Scientific Title of Study
|
An Interventional study to Evaluate the Efficacy of Microneedling with Platelet Rich Fibrin in the treatment of post Acne atrophic 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 Alapati Spandana |
| Designation |
Post Graduate |
| Affiliation |
Sri Venkateshwaraa Medical College hospital & research centre |
| Address |
Department of Dermatology, Venereology and Leprology, Sri Venkateshwaraa Medical College hospital & research centre. Ariyur.
PONDICHERRY
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8985024941 |
| Fax |
|
| Email |
spandana.alapati91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roshni Menon |
| Designation |
Professor and Head of the Department (Guide) |
| Affiliation |
Sri Venkateshwaraa Medical College hospital & research centre |
| Address |
Department of Dermatology, Venereology and Leprology, Sri Venkateshwaraa Medical College hospital & research centre. Ariyur. Pondicherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9443208140 |
| Fax |
|
| Email |
roshnijagdish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Trishna Vaishali M |
| Designation |
Assistant Professor (Co Guide) |
| Affiliation |
Sri Venkateshwaraa Medical College hospital & research centre |
| Address |
Department of Dermatology, Venereology and Leprology, Sri Venkateshwaraa Medical College hospital & research centre. Ariyur. Pondicherry
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9840579316 |
| Fax |
|
| Email |
trishpraveen@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Alapati Spandana |
| Address |
Post Graduate, Department of Dermatology, Venereology & Leprology, Sri Venkateshwaraa Medical College Hospital & Research Centre,Ariyur, Pondicherry-605102 |
| Type of Sponsor |
Other [Self Funding] |
|
|
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 Alapati Spandana |
Sri Venkateshwaraa Medical College Hospital and Research Centre |
Department of Dermatology,Venereology and Leprology, Sri Venkateshwaraa Medical College Hospital and Research Centre, Ariyur, Puducherry-605102
Pondicherry
PONDICHERRY |
8985024941
spandana.alapati91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Sri Venkateshwaraa Medical College Hospital & Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L709||Acne, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Microneedling will be done with a dermapen followed by platelet rich fibrin application. |
It will be done for 3 sessions, at an interval of 4 weeks with follow up after 4 weeks of last session |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with clinical diagnosis of acne scars .
2. Patients with age 18 years and above.
|
|
| ExclusionCriteria |
| Details |
1. Patient with active acne lesions
2. Pregnant and breastfeeding women.
3. Patients on anticoagulant therapy.
4. Patients with active herpes, HIV, Hep B, Hep C infection.
5. Patient with history of keloids.
6. Patient with haemoglobin less than10 mg /dl , platelet count less than 1lakh /cm3
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Improvement in the grade of scar using Goodman and Barons acne scar grading system
|
Baseline and 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction |
Baseline and 12 weeks. |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
31/03/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Each patient will be enrolled based on the inclusion and exclusion criteria.A detailed history and examination will be done . Patients on oral retinoids will be advised to stop taking the medications . The patient will be put on sunscreen atleast two weeks prior to the procedure. The scar site will be subjected to microneedling followed by platelet rich fibrin application. Each patient will receive 3 sessions at a interval of 4 weeks (monthly once for 3 months) and then follow up after 4 weeks ( 1 month) of last session. (Total 4 visits for each patient). Pre and post procedure assessment of scar will be done by Goodman and Barons acne scar grading system and results will be statistically analysed. |