A three-month clinical study to evaluate the effectiveness of the device in body shaping

A Clinical Evaluation of the Efficacy of the Density Device for Non-Invasive Body Contouring over a 3-Month Period - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/08/093106

Enrollment

Registered

2025-08-14

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 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, resulti

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female Trial participants aged between 25-60 years. 2. Skin Laxity: Visible mild to moderate skin laxity or sagging. 3. Participants who agree to maintain their existing lifestyle- dietary habits and 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 willing to comply with the protocol. 6. 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. 2. Trial participants with severe skin redundancy. 3. Trial participants currently taking any medication which the investigator believes may influence the interpretation of the data. 4. 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. 5. Trial participants who are pregnant or nursing (self-declared). 6. A known history or present condition of allergic response to any skincare or cosmetic treatments/procedures. 7. Trial participant who is an employee of the sponsor or the CRO.

Design outcomes

Primary

Measure	Time frame
Changes in body contour of the treatment site in comparison to baseline based on dermatological and instrumental evaluationsTimepoint: Day 1 or 2, Day 30, Day 90 and Day 210	—

Secondary

Measure	Time frame
Perceived changes of the treatment site in comparison to baseline based on patient reported outcome.Timepoint: Day 1 or 2, Day 30, Day 90 & Day 210	—

Countries

India

Contacts

Public ContactSudhanthiran S

MS Clinical Research Pvt. Ltd.

ritambhara@msclinical.com09080826918

Outcome results