Health Condition 1: 8- Other Procedures
Conditions
Interventions
Intervention1: 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, result
Sponsors
Jeisys Medical Inc.
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Timepoint: Day 1 or 2, Day 30 and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Day 1 or 2, Day 30 and Day 90 | — |
Countries
India
Contacts
Public ContactSoniya Wills
M S CLINICAL RESEARCH PVT.LTD
Outcome results
None listed