A 6-months study to test the device effectiveness in facial skin improvement.

A clinical study to evaluate the efficacy of the Density device for facial rejuvenation in female trial participants over 3-months period. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/08/093107

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 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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 assessmentsTimepoint: Day 1 or 2, Day 30, Day 90, Day 180	—

Secondary

Measure	Time frame
Perceived changes in facial rejuvenation from baseline, as evaluated through participant feedback questionnairesTimepoint: Day 1 or 2, Day 30, Day 90, Day 180	—

Countries

India

Contacts

Public ContactSudhanthiran S

MS Clinical Research Pvt. Ltd

ritambhara@msclinical.com08040917253

Outcome results