| CTRI Number |
CTRI/2024/10/075145 [Registered on: 11/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of microneedling Comparing with Topical Insulin and Topical Vitamin c in the Treatment of Post Acne Atrophic Scars. |
|
Scientific Title of Study
|
A Comparative Study to Assess the Efficacy and safety of Micro
needling with Topical insulin versus Microneedling with Topical vitamin C in the treatment of Post acne atrophic 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 |
Dr RAMYA DEVI G |
| Designation |
Post graduate |
| Affiliation |
The Tamil Nadu Dr .M G.R. Medical university,chennai. |
| Address |
Dept of DVL Stanley medical college and hospital no 1 old jail road, George Town, Chennai. Tamil Nadu.
Chennai
TAMIL NADU
600001
India |
| Phone |
9445224727 |
| Fax |
|
| Email |
drramyacmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anandan V |
| Designation |
Professor and HOD |
| Affiliation |
The Tamil Nadu Dr .M G.R. Medical university,chennai. |
| Address |
Dept of DVL Stanley medical college and hospital no 1 old jail road ,george town, chennai 01
Chennai
TAMIL NADU
600001
India |
| Phone |
9841043213 |
| Fax |
|
| Email |
dermanandan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anandan |
| Designation |
Professor and HOD |
| Affiliation |
The Tamil Nadu Dr .M G.R. Medical university,chennai. |
| Address |
Dept of DVL Stanley medical college and hospital no 1 old jail road ,george town, chennai 01
Chennai
TAMIL NADU
600001
India |
| Phone |
9841043213 |
| Fax |
|
| Email |
dermanandan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Stanley Medical College and Hospital, No 1,Old Jail Road George Town chennai -600001 |
|
|
Primary Sponsor
|
| Name |
Dr RAMYA DEVI G |
| Address |
Dept of DVL stanley medical college Chennai 600001 |
| Type of Sponsor |
Other [SELF] |
|
|
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 RAMYA DEVI G |
Govt Stanley Medical College and Hospital |
Department of DVL, Room no 81,1st floor Super specialty block Chennai
Chennai
TAMIL NADU |
09445224727
drramyacmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOVERNMENT STANLEY MEDICAL COLLEGE CHENNAI.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 |
Topical Human actrapid Insulin 40IU O.25 Ml applied topically in each face. |
after microneedling Topical Insulin 0.25 ml applied then wiped after 30 minutes.strict photo protection to be maintained. 4 weeks interval following 4 months |
| Comparator Agent |
topical VITAMIN C 10-15% |
Following microneedling topical vitamin c is applied for patients with post acne atropic scar for 4 weeks interval.for 4 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. patients clinically with atrophic acne scars
2. patients willing for consent,procedures and followup
both sexes
3 patients willing to take clinical photos |
|
| ExclusionCriteria |
| Details |
1.Active acne
2. Herpes simplex
3.H/o keloidal tendency
4Patients taking treatment with systemic drugs
5.patients with co morbiditis
6 pregnancy and lactation mothers |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assessed by decreasing acne scar by serial Photographic assessment by goodman and baron scoring system. |
every month for 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| subjective satisfaction will be assessed by patients self assessment through the following set of questionaries |
after 4 months |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
17/11/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is Prospective ,open labelled Interventional study, comparing the efficacy of Microneedling with Topical Insulin versus Microneedling with topical Vitamin c post acne Atrophic scars that will be conducted in Dermatology Opd in Government Stanley medical college and hospital With sample size 34 divided by simple randomisation method into two groups .duration of study is 1 year from June2024 to May 2025. |