None listed
Conditions
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, result
Sponsors
Jeisys Medical Inc.
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Timepoint: Day 2, Day 30, Day 90 and Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Day 2, Day 30, Day 90 & Day 180 | — |
Countries
India
Contacts
Public ContactSoniya Wills
M S CLINICAL RESEARCH PVT.LTD
Outcome results
None listed