| CTRI Number |
CTRI/2025/08/093107 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
A 6-months study to test the device effectiveness in facial skin improvement. |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of the Density device for facial rejuvenation in female trial participants over 3-months period. |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| SKIN/JSFR/2025-02 Version 2.0 dated 18 Sep 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
327/15, 1st Main Road Cambridge layout, Ulsoor
Department of skin sciences, 324, Second Floor, 1st Main Road, Cambridge Layout, Ulsoor,
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ritambhara |
| Designation |
Director business and operation |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
327/15, 1st Main Road Cambridge layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
ritambhara@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Sudhanthiran S |
| Designation |
Manager - Techno-commercial |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
327/15, 1st Main Road, Cambridge layout Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
08040917253 |
| Fax |
|
| Email |
sudhan@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Jeisys Medical Inc., #307, 96, Gamasan-ro, Geumcheon-gu, Seoul, South Korea (ZIP 08501) |
|
|
Primary Sponsor
|
| Name |
Jeisys Medical Inc. |
| Address |
#307, 96, Gamasan-ro, Geumcheon-gu, Seoul, South Korea (ZIP 08501) |
| Type of Sponsor |
Other [Medical Device] |
|
|
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 Mukta Sachdev |
MS Clinical Research Pvt. Ltd |
Department of Skin Sciences,
#324, Second Floor, 1st Main Road, Cambridge Layout, Ulsoor, Bangalore - 560008, Karnataka, India
Bangalore
KARNATAKA |
08040917253
mukta.sachdev@msclinical.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
| ACE Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Female Participants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DST101 |
It is a general-purpose electrosurgical device and treats using RF frequency. When high RF is irradiated on the skin, coagulation occurs with heat action of skin tissue, resulting in tissue treatment. |
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Female trial participants aged between 30-50 years.
2. Trial participants with Skin toning or lifting score of 2-5 as evaluated by the dermatological visual assessment scale.
3. Participants who agree to maintain their existing skincare routine throughout the study duration.
4. Trial participants able to read, speak, write and understand the informed consent form and provide consent for study procedures.
5. Trial participants who are willing to have standardized clinical photographs taken of the treatment areas at all study visits for documentation and evaluation purposes.
|
|
| ExclusionCriteria |
| Details |
1. Trial participants with known active skin infections.
2. Trial participants currently taking any medication which the investigator believes may influence the interpretation of the data.
3. Trial participants who are pregnant or nursing (self-declared).
4. A known history of allergic response to any skincare or cosmetic treatment/ procedures.
5. A known history of allergic response to any skincare or cosmetic treatment/ procedures.
6. Trial participants having any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious/chronic medical illness or have undergone major surgery in the last year.
7. Trial participant who is an employee of the sponsor or the CRO.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Change in skin toning or lifting, fine lines, nasolabial fold, smoothness visual & tactile, appearance of pores and global hyperpigmentation, assessed using dermatologist evaluation and instrumental assessments |
Day 1 or 2, Day 30, Day 90, Day 180 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Perceived changes in facial rejuvenation from baseline, as evaluated through participant feedback questionnaires |
Day 1 or 2, Day 30, Day 90, Day 180 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/08/2025 |
| Date of Study Completion (India) |
20/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/04/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study aims to evaluate the efficacy of the Density device over a three-month period, with a specific focus on outcomes related to facial rejuvenation involving both dermatological assessments and instrumental measurements, alongside patient-reported outcomes, to comprehensively assess treatment performance. Female participants aged 30 to 50 years will be enrolled, and a total of four visits will be scheduled for each participant. Visit 1 for screening, visit 2 for baseline, procedure and immediate post procedure assessment, and follow-up assessment visits on day 30 (visit 3) day 90 (visit 4) and day 180 (visit 5). Safety will be monitored throughout the study to identify any adverse effects.
|