Evaluation of Efficacy and Safety of the triLift™ System

Not Applicable

Recruiting

• Conditions: Skin Laxity; Wrinkle
• Interventions: Device: triLift system

• Registration Number: NCT05773924
• Lead Sponsor: Lumenis Be Ltd.

Brief Summary

Single center, single-arm, prospective, open Label with Before \& After Study Design.

Detailed Description

Single center, single-arm, prospective, open Label with Before \& After Study Design. The control group will be the subjects before the triLift™ treatment protocol and the experimental group will consist of the same subjects after completion of the triLift™ treatment protocol.

Study Timeline

• Status Verified: 2023-02
• Study Start: 2023-02-10
• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-03-06
• Last Update Submitted: 2023-03-06
• Study First Posted: 2023-03-17
• Last Update Posted: 2023-03-17
• Primary Completion: 2023-08-15
• Study Completion: 2023-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Subject is willing and able to read, understand, and sign the informed consent.
• Healthy male or female aged 35 - 55 years.
• Fitzpatrick skin type 1-6.
• Subject is capable of reading, understanding, and following instructions of the procedure to be applied.
• Subject is able and willing to comply with the treatment. Women in childbearing age who is willing to conduct a pregnancy test prior to each treatment.

Exclusion Criteria

• Pregnant, lactating, or plans to become pregnant during the study period or had given birth less than 6 months ago.
• Concurrent participation in any other study.
• Subject has a pacemaker or internal defibrillator, implanted neurostimulators or any other internal electric device or patient who had an implant in the past.
• Subject has metal or other implants in the treatment area (Not including dental fillings, implants and crowns).
• Subject has significant concurrent skin conditions affecting areas to be treated such as sores, bleeding, skin fragility, eczema or psoriasis.
• Subject has burned, blistered, irritated, or sensitive skin due to excessive fresh tanning in areas to be treated or is unlikely to refrain from excessive tanning during the study.
• Subject has used oral isotretinoin (Accutane® or Roaccutan®) within 6 months prior to study.
• Subject has used topical retinoids in the past 1 month.
• History of systemic cancer; premalignant skin lesion or skin concern treatment area.
• Concurrent conditions such as epilepsy, autoimmune, pulmonary or cardiac disorders.
• Poorly controlled endocrine disorders such as diabetes.
• Impaired immune system due to immunosuppressive diseases such as HIV or AIDS, or use of immunosuppressive medications.
• History of collagen disorders, keloid formation or abnormal wound healing.
• Takes or has taken medications, herbal preparations, food supplements or vitamins that might cause fragile skin or impaired skin healing.
• Subject has used oral steroids in the past 6 months.
• Subject has used topical steroids in the past 3 months.
• History of bleeding coagulopathies or use of anticoagulants.
• Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen containing agents) one week before and after each treatment session prior to treatment.
• Subjects who cannot feel heat to give proper treatment feedback. (nerve damage, etc.)
• Mental disorders that in the opinion of the Investigator would interfere with the ability to comply with the study requirements.
• Subject has any other medical condition that in the opinion of the Investigator warrants exclusion from this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trilift system treatment arm	triLift system	Single arm with Before \& After photos, triLift treatment protocol study design.

Primary Outcome Measures

Name	Time	Method
The Global Aesthetic Improvement scale (GAI)	4 months	The Global Aesthetic Improvement scale (GAI) - Success is defined as an improvement of at least 1 point on the GAI scale assessed by the investigator, at the end of the treatment protocol as compared to baseline.

Secondary Outcome Measures

Name	Time	Method
3D images	4 months	Measuring facial lifting using 3D imaging and analysis algorithm from Quantificare before and after the treatment protocol
Comfort assessment	3 months	Subject assessment of pain and discomfort associated with treatments using a Pain Visual Analogue Scale (VAS), where 0 is "no pain" and 10 is "worst pain possible
Subject level of Satisfaction	4 months	Subject satisfaction will be assessed using a 5 level satisfaction questionnaire.

Trial Locations

Locations (1)

NY Laser Skin Care; 🇺🇸 New York, New York, United States