| CTRI Number |
CTRI/2017/12/010983 [Registered on: 27/12/2017] Trial Registered Prospectively |
| Last Modified On: |
26/12/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between subcision using needle vs subcision using radiofrequency in treatment of post acne scars. |
|
Scientific Title of Study
|
A split face randomized control study comparing
the efficacy and safety of intralesional radiofrequency assisted subcision versus Conventional subcision in Post acne Scars
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maninder Kaur |
| Designation |
Junior Resident |
| Affiliation |
AIIMS |
| Address |
Skin OPD,Rajkumari Amrit Kaur OPD,1 st floor,AIIMS
Department of Dermatology and Venereology, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
8860118442 |
| Fax |
01126594351 |
| Email |
manu31aug@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Somesh Gupta |
| Designation |
Professor |
| Affiliation |
AIIMS |
| Address |
Skin OPD,Rajkumari Amrit Kaur OPD,1st floor
South
DELHI
110029
India |
| Phone |
01126596626 |
| Fax |
|
| Email |
someshgupta@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Somesh Gupta |
| Designation |
Professor |
| Affiliation |
AIIMS |
| Address |
Skin OPD,Rajkumari Amrit Kaur OPD,1st floor
West
DELHI
110029
India |
| Phone |
01126596626 |
| Fax |
|
| Email |
someshgupta@hotmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Maninder Kaur |
AIIMS Skin OPD, Minor OT. |
RAK OPD,1st floor,AIIMS,New Delhi
South
DELHI |
8860118442
manu31aug@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee for post graduate Research,AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Post Acne scars patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Excision |
For conventional subcision number 18 or 20 gauge needle will be inserted adjacent to the scar with the bevel upwards parallel to the skin surface, into the deep dermis and moved back and forth in a fan-like motion under the scar to release fibrous bands at dermal or deep dermal subcutaneous plane. |
| Intervention |
Radiofrequency assisted subcision |
Before doing the procedure, local anaesthesia will be given.
Intralesional Radiofrequency assisted subcision will be done
in cutting mode with low power. In this procedure a small window will be created at the proximal end of the plastic sheath of an 22 G intravenous cannula with the help of a surgical blade. The plastic sheath provides insulation and prevents damage to the skin at the entry point. Then the cannula will be inserted superficially into the scarred area parallel to skin surface. The electrosurgery probe will be touched to the trochar of the cannula through the window.
Simultaneously, the cannula along with probe overlying it will be moved back and forth in a fan like motion under the scars to release fibrous bands at dermal or deep dermal subcutaneous plane. Care will be taken to avoid the preauricular, temporal areas to avoid injuries to facial nerve and major vessels.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) All patients with mild to moderate atrophic acne scars over both cheeks.
2) Age >18 years.
3) Acne in remission on and off therapy for more than 1 month.
|
|
| ExclusionCriteria |
| Details |
1) Age group < 18 years
2) Active acne lesions
3) Active infection at treatment site
4) Pregnancy and lactation
5) Tendency of Keloid formation
6) Cardiac pacemakers
7) Metallic implants
8) Bleeding diathesis or on anticoagulants
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to see the efficacy and side effects of both types of techniques used for post acne scars.Photographic assessment by two uninvolved dermatologists will be done.Both patient and physician assesment grading will be done. |
Two sittings 2 week apart will be done.At 1 month and 3 month after last sitting. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To note the side effects and safety of both types of procedure |
At the time of 2nd sitting at 2 weeks and then 1 month and 3 month after 1st sitting |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 4 |
|
Date of First Enrollment (India)
|
30/12/2017 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Subcision is a commonly done procedure for depressed rolling scars of acne.However, the excessive mechanical force often leads to trauma to the surrounding tissue,excessive bleeding, and large hematoma formation and fibrosis. We propose the use of radiofrequency energy in place of mechanical energy for subcision so that the fibrotic strands get cut with ease without much mechanical force. |