| CTRI Number |
CTRI/2024/01/061965 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Atrophic munhase nishan mein aanshik carbon dioxide laser banaam micronedaling eath derma pen ka ek tulnatmak adhyayan
|
|
Scientific Title of Study
|
A comparative study of efficacy of microneedling with derma pen versus fractional carbon dioxide laser in atrophic acne scars |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| aadhar card |
Protocol Number |
| Protocol numer - ECR/717/Inst./U.P./2015/RR-21 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Savita Chaudhary |
| Designation |
Professor |
| Affiliation |
era lucknow ,medical college lucknow |
| Address |
Depatment of dermatology , Roon number - 4
sarfarazganj lucknow 222006
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9728540766 |
| Fax |
|
| Email |
savitachaudhary1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rinki Tayal |
| Designation |
resident |
| Affiliation |
era lucknow ,medical college lucknow |
| Address |
sarfarazganj lucknow 222006
sarfarazganj lucknow 222006
UTTAR PRADESH
226003
India |
| Phone |
9728540766 |
| Fax |
|
| Email |
tayalrinki1996@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rinki Tayal |
| Designation |
resident |
| Affiliation |
era lucknow ,medical college lucknow |
| Address |
Department of dermatology, venerology and leprosy
Room number-4
sarfarazganj lucknow 222006
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9728540766 |
| Fax |
|
| Email |
tayalrinki1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Eras lucknow medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Dr Rinki Tayal |
| Address |
Girls hostel eras lucknow medical college Lucknow |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DrSavita Chaudhary |
eras lucknow medical college Lucknow |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| rinki tayal |
eras lucknow medical college and hospital |
Department of dermatology, venerology, and leprosy
Room number - 4
Lucknow
UTTAR PRADESH |
9728540766
tayalrinki1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CO2 laser |
CO2 laser will be used in acne scars patient who are giving consent
Total time of my trail is 24 months. |
| Comparator Agent |
dermapen |
Dermapen will be used in acne scars patient who are giving consent
Total time of my trail is 24 months |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient with age more than 16 years having atrophic acne scars.
2. Absence of active acne lesions |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Both medthods are good
|
Both medthods are good
And result will be modify at baseline,4 week , 8 week and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| good |
7 |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 02-02-2024 and end date provided 28-12-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
I am doing CO2 laser and dermapen in acne scars patients to know which is better for scars . I am waiting for CTRI approval |