| CTRI Number |
CTRI/2024/02/062522 [Registered on: 12/02/2024] Trial Registered Prospectively |
| Last Modified On: |
08/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Other (Specify) [Therapeutic ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study of micro -needling versus micro-needling with platelet rich plasma in facial acne scars |
|
Scientific Title of Study
|
Efficacy of micro-needling with platelet rich plasma versus micro-needling alone in facial acne scars -A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mogalipuvvu udayasri |
| Designation |
1st year post graduate |
| Affiliation |
Aarupadai Veedu medical college and hospital |
| Address |
A block , ground floor , dept of dermatology,Aarupadai Veedu medical college and hospital ,Kirumampakkam,puducherry.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
7028513817 |
| Fax |
|
| Email |
mogalipuvvuudayasri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDamayandhi K |
| Designation |
Associate professor |
| Affiliation |
Aarupadai Veedu medical college |
| Address |
A block , ground floor , dept of dermatology,Aarupadai Veedu medical college and hospital ,Kirumampakkam,puducherry.
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9488511884 |
| Fax |
|
| Email |
deepakaliyaperumal@gmail.con |
|
Details of Contact Person
Public Query
|
| Name |
Mogalipuvvu udayasri |
| Designation |
1st year postgraduate |
| Affiliation |
Aarupadai Veedu medical college and hospital |
| Address |
A block , ground floor , dept of dermatology,Aarupadai Veedu medical college and hospital ,Kirumampakkam,puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
7028513817 |
| Fax |
|
| Email |
Mogalipuvvuudayasri@gmail.con |
|
|
Source of Monetary or Material Support
|
| Aarupadai Veedu medical college ,Pondicherry. |
|
|
Primary Sponsor
|
| Name |
Aarupadai Veedu medical college ,Pondicherry |
| Address |
Aarupadai Veedu medical college,Kirumampakkam,Pondicherry. |
| 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 |
| Mogalipuvvu Udayasri |
Aarupadai Veedu medical college and hospital |
A block ,ground floor,Department of dermatology,venereology,leprologyAarupadai Veedu medical college ,Kirumampakkam,Pondicherry.
Pondicherry
PONDICHERRY |
7028513817
mogalipuvvuudayasri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Avmc instituitional ethics committee |
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 |
| Comparator Agent |
Micro-needling alone |
Micro-needling alone at 0.4,8,12 weeks |
| Intervention |
Micro-needling with platelet rich plasma |
Micro-needling with platelet rich plasma at 0,4,8 and 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Both genders.
2) Age above 18 years .
3)Patient willing for follow up.
4) Patients with Goodman and Baron grade 2,3,4 acne scars. |
|
| ExclusionCriteria |
| Details |
1)Presence of active
2) Keloidal tendency.
3) On oral steroids
4) On anticoagulants .
5) Any active infection like herpes.
6) Pregnancy.
7) Patients with bleeding disorders . |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Global Aesthetic Improvement Scale (GAIS) |
At baseline,4 ,8,12 weeks & follow up for 2 months at monthly intervals |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Goodman & baron scale,patient selfsatisfaction scale |
At baseline ,4 weeks,8 weeks ,12 weeks & 2 months follow up at monthly intervals |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
17/02/2024 |
| 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="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
|
Acne vulgaris is a universal disease affecting about 9.4% population globally(2). Around 90% people get affected in their teens & in some it persists till adulthood. In India prevalence rate is about 50.60% in males and 38.13% in females, in age group of 12-17 year(3). Abnormal resolution or wound healing following the damage that occurs in sebaceous follicle during inflammation results in post acne scarring. |