| CTRI Number |
CTRI/2025/10/096688 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to see if the Density Device helps improve loose skin in people losing weight with GLP-1/GIP medicines. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial Evaluating the Efficacy of the Density Device in Skin Laxity among Trial Participants Undergoing GLP-1/GIP Therapy for Weight Loss. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/JSWR/2025-03, version 1.0 |
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,
36-1, Second Floor, Admin Block
1st Main Road, Cambridge Layout,
Ulsoor
MS Clinical Research Pvt. Ltd,
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 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 |
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 |
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 |
| Dr Mukta Sachdev |
MS Clinical Research Pvt. Ltd |
MS Clinical Research Pvt. Ltd,
36-1, Second Floor, Admin Block
1st Main Road, Cambridge Layout,
Ulsoor, Bangalore - 560008, Karnataka, India
Phone: +91 8040917253
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 |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DST 101 |
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 procedure will be performed only once on Day 1 or Day 2 following the completion of baseline assessments. |
| Comparator Agent |
GLP-1/GIP treatment |
These are modern treatments that help with weight loss |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Trial participants receiving GLP-1/GIP therapy for weight loss.
2. Trial Participants who agree to maintain their existing lifestyle- dietary habits (i.e., no major changes in diet or exercise routines) and skincare routine throughout the study duration.
3. Trial participants able to read, speak, write and understand the informed consent form and provide consent for study procedures.
4. Trial participants who are willing to have standardized clinical photographs taken of the treatment areas at all study visits for documentation and evaluation purposes.
5. Trial participants who are willing to undergo the treatment procedure.
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, eczema, hypertrophic scarring, keloids, 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. Received face and body contouring treatments (surgical or non-surgical) or skin-tightening procedures in the target area within the last 6 months.
3. Trial participants with severe skin redundancy or panniculus (hanging skin folds) requiring surgical intervention such as panniculectomy.
4. Implants or Devices: Metal implants, pacemakers, or defibrillators near the treatment area.
5. Trial Participants who are currently taking any medication other than GLP-1 or Any medication which, in the opinion of the investigator, may influence the interpretation of the study data.
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 Participants who have followed a crash diet or initiated a rigorous exercise program within the past 1 to 3 months prior to study enrollment.
8. Trial participants who are pregnant or nursing (self-declared).
9. A known history or present condition of allergic response to any skincare or cosmetic treatments/procedures.
10. 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
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Changes in skin toning or lifting, texture, fine Lines, nasolabial fold, visibility of pores, elasticity, Hyperpigmentation, Dermal density and epidermal thickness of the treatment sites (Face and neck) in comparison to baseline and control (group 2) based on dermatological and instrumental evaluations.
2. Perceived changes of the treatment sites in comparison to baseline and control (group 2) based on patient reported outcomes.
|
Day 1 or 2, Day 30 and Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in skin toning or lifting, texture, elasticity, Dermal density and epidermal thickness of the treatment site (Inner Upper arm region) in comparison to baseline and control group (group 2) based on dermatological and instrumental evaluations.
2. Perceived changes of the treatment site (Inner Upper arm region) in comparison to baseline and control group (group 2) based on patient reported outcome. |
Day 1 or 2, Day 30 and Day 90 |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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)
|
11/11/2025 |
| 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
|
Years="0"
Months="3"
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 clinical study is designed to evaluate the safety and efficacy of an investigational device for improving skin laxity in the face, neck, and inner upper arm regions over a 3-month period. After providing informed consent and meeting eligibility criteria, participants will undergo baseline assessments and treatment, followed by immediate post-procedure evaluation and telephonic follow-up within 48 hours. Follow-up visits will be conducted on Day 30 and Day 90 to assess treatment outcomes, safety, and participant satisfaction through repeat imaging, dermatological and instrumental assessments, and questionnaires. The study will conclude at Day 90 with final evaluations and completion of the exit formalities. |