| CTRI Number |
CTRI/2025/11/097428 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A 3-Month study to see how the Density Device improves the look of skin around the eyes |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy
of the Density device for periorbital
rejuvenation over 3-months period. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/JSPR/2025-04 version 1.0 dated 10 Oct 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 |
MS Clinical Research Pvt. Ltd,
Department of Skin Sciences,
#324, Second Floor, 1st Main Road, Cambridge
Layout, Ulsoor
Procedures- MS Clinical Research Pvt. Ltd,
36-1, Second Floor, Admin Block
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 operations |
| Affiliation |
M S CLINICAL RESEARCH PVT.LTD |
| Address |
MS Clinical Research Pvt. Ltd,
327/15,1st Main Road, Cambridge
Layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
09952700028 |
| Fax |
|
| Email |
ritambhara@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Soniya Wills |
| Designation |
manager- operations |
| Affiliation |
MS Clinical Research Pvt. Ltd |
| Address |
MS Clinical Research Pvt. Ltd,
327/15,1st Main Road, Cambridge
Layout, Ulsoor
Bangalore
KARNATAKA
560008
India |
| Phone |
09952700028 |
| Fax |
|
| Email |
soniya@msclinical.com |
|
|
Source of Monetary or Material Support
|
| Jeisys Medical Inc.
Address #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 = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mukta Sachdev |
MS Clinical Research Pvt. Ltd |
36-1, Second Floor, Admin Block
1st Main Road, Cambridge Layout,
Ulsoor
Bangalore
KARNATAKA |
08040917253
mukta.sachdev@msclinical.com |
| Dr Mukta Sachdev |
MS Clinical Research Pvt. Ltd |
Department of Skin Sciences,
#324, Second Floor, 1st Main Road, Cambridge
Layout, Ulsoor
Bangalore
KARNATAKA |
08040917253
mukta.sachdev@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Male & Female trial 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. The treatment will be performed on day 1 or 2 following the completion of baseline assessments |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Male & Female trial participants aged between 30-60 years (both ages inclusive).
2. Participants who agree to maintain their existing skincare routine throughout the study
duration.
3. Trial participants with Skin toning or lifting score of 2-5 as evaluated by the
dermatological visual assessment scale.
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.
6. Trial participants willing to comply with the protocol.
7. Trial participants willing to give a voluntary written informed consent, photography
release and agree to come for regular follow-up. |
|
| ExclusionCriteria |
| Details |
1. Trial participants with known active skin infections, open wounds, dermatitis, or eczema, hypertrophic scarring, keloids and connective tissue disorders (self-declared) or dormant dermatological conditions at the treatment site (e.g., psoriasis, rosacea, seborrheic dermatitis, vitiligo, or disorders of hyperpigmentation or hypopigmentation).
2. Trial participants with recent treatment / Procedures on the test area (surgical or nonsurgical) or skin-tightening procedures in the target area within the last 6 months.
3. Trial participants having any implants or device near the treatment area.
4. Trial participants currently taking any medication which the investigator believes may influence the interpretation of the data.
5. Trial participants who have participated in a similar clinical study 4 weeks before this study.
6. Trial participants who are pregnant or nursing (self-declared).
7. A known history of allergic response to any skincare or cosmetic treatment/
procedures.
8. 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.
9. Trial participant who is an employee of the sponsor or the CRO. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Change in fine skin toning, fine lines & wrinkles on periorbital region as evaluated by dermatological assessments at all timepoints compared to baseline.
2. Change in skin texture, fine lines & pigmentation on periorbital region by Antera 3D at all timepoints compared to baseline.
|
Day 2, Day 30, Day 90 and Day 180 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Change in melanosis, Skin texture, puffiness on periorbital region as evaluated by dermatological assessments at all timepoints compared to baseline
2. Perceived changes in periorbital rejuvenation from baseline, as evaluated through participant feedback questionnaires. |
Day 2, Day 30, Day 90 & Day 180 |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
22/11/2025 |
| 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
Modification(s)
|
Years="0"
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
Modification(s)
|
This clinical study is a baseline-controlled, efficacy and safety evaluation of the Density device for periorbital rejuvenation conducted over approximately 6 months. Following informed consent and screening (Visit 1), eligible participants will undergo baseline assessments, the study procedure, and immediate post-procedure evaluations (Visit 2). Imaging, dermatological, and instrumental assessments will be performed to document baseline skin condition, followed by the device procedure conducted as per protocol. Participants will be monitored for any adverse events and receive post-care instructions, with a telephonic follow-up within 48 hours. Subsequent follow-up visits will be conducted on Day 30 (Visit 3), Day 90 (Visit 4) and Day 180 (Visit 5) to assess treatment efficacy, participant satisfaction, and safety outcomes through repeat imaging, dermatological and instrumental assessments, and questionnaires. The final visit (Day 180) will conclude the study with end-of-participation documentation. |