| CTRI Number |
CTRI/2024/05/067801 [Registered on: 22/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to observe the effects of a treatment option for acne scars |
|
Scientific Title of Study
|
The efficacy and safety of MNRF with PRP or MNRF alone in the treatment of facial acne scars in patients at a tertiary care teaching hospital- a prospective observational 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 |
Dr Silpa Rajesh Raj |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Room number 21
Department of Dermatology, Venereology and Leprosy
Old OPD Block
Skin OPD
Kasturba Hospital Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7022889250 |
| Fax |
|
| Email |
silparaj4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sathish Pai B |
| Designation |
PROFESSOR AND HOU |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Room number 21
Department of Dermatology, Venereology and Leprosy
Old OPD Block
Skin OPD
Kasturba Hospital Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9900405072 |
| Fax |
|
| Email |
drsbpai@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sathish Pai B |
| Designation |
Professor and HOU |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Room number 21
Department of Dermatology, Venereology and Leprosy
Old OPD Block
Skin OPD
Kasturba Hospital Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9900405072 |
| Fax |
|
| Email |
drsbpai@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal for infrastructural support |
|
|
Primary Sponsor
|
| Name |
Dr Silpa Rajesh Raj |
| Address |
Room number 21
Department of Dermatology, Venereology and Leprosy
Old OPD Block
Skin OPD
Kasturba Hospital Manipal
Pin- 576104 |
| 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 Silpa Rajesh Raj |
Kasturba Hospital Manipal |
Room number 21
Department of Dermatology, Venereology and Leprosy
Old OPD Block
Skin OPD
Kasturba Hospital Manipal
Udupi
KARNATAKA |
7022889250
silparaj4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, (2) ICD-10 Condition: L705||Acne excoriee, (3) ICD-10 Condition: L708||Other acne, (4) ICD-10 Condition: L709||Acne, unspecified, (5) ICD-10 Condition: L905||Scar conditions and fibrosis of skin, (6) ICD-10 Condition: L909||Atrophic disorder of skin, unspecified, (7) ICD-10 Condition: L908||Other atrophic disorders of skin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with acne scarring aged 18 years or above are included. |
|
| ExclusionCriteria |
| Details |
Those with known photosensitivity, pregnancy, lactation, keloidal tendency, use of oral retinoids in last 6 months, infections like herpes labialis and history of pacemaker implantation are excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the improvement of facial acne scars qualitatively, quantitatively and subjectively in terms of percentages. To monitor the various side effects that can occur during the procedure. |
Monthly for 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the various side effects that can occur during the procedure. |
Monthly for 4 months |
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
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)
|
01/06/2024 |
| 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 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
|
This study is done to observe the efficacy of MNRF (Microneedling radiofrequency) with PRP (Platelet rich plasma) or MNRF alone in treating acne scars. We will be assessing the qualitative, quantitative and subjective improvement using relevant grading system. This study will not be comparing MNRF alone and MNRF with PRP. It is simply observing all patients undergoing either procedure for any improvement. It is a relatively new method for the treatment of facial acne scars and there is very limited data assessing its efficacy on Indian skin types. |