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Evaluation of Efficacy and Safety of the triLift™ System (LUM-triLift)

Primary Purpose

Skin Laxity, Wrinkle

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
triLift system
Sponsored by
Lumenis Be Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Laxity focused on measuring laxity, facial lifting, wrinkles, rhytids

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • NY Laser Skin CareRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Trilift system treatment arm

Arm Description

Single arm with Before & After photos, triLift treatment protocol study design.

Outcomes

Primary Outcome Measures

The Global Aesthetic Improvement scale (GAI)
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

3D images
Measuring facial lifting using 3D imaging and analysis algorithm from Quantificare before and after the treatment protocol
Comfort assessment
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
Subject satisfaction will be assessed using a 5 level satisfaction questionnaire.

Full Information

First Posted
February 23, 2023
Last Updated
March 6, 2023
Sponsor
Lumenis Be Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05773924
Brief Title
Evaluation of Efficacy and Safety of the triLift™ System
Acronym
LUM-triLift
Official Title
Evaluation of Efficacy and Safety of the triLift™ System
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lumenis Be Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity, Wrinkle
Keywords
laxity, facial lifting, wrinkles, rhytids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trilift system treatment arm
Arm Type
Other
Arm Description
Single arm with Before & After photos, triLift treatment protocol study design.
Intervention Type
Device
Intervention Name(s)
triLift system
Intervention Description
To evaluate the efficacy of the triLift™ treatment
Primary Outcome Measure Information:
Title
The Global Aesthetic Improvement scale (GAI)
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
3D images
Description
Measuring facial lifting using 3D imaging and analysis algorithm from Quantificare before and after the treatment protocol
Time Frame
4 months
Title
Comfort assessment
Description
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
Time Frame
3 months
Title
Subject level of Satisfaction
Description
Subject satisfaction will be assessed using a 5 level satisfaction questionnaire.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fiona Kerr
Phone
212-249-9440
Email
nurses@nylaserskincare.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arielle Kauvar, MD
Organizational Affiliation
New York Laser & Skin Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
NY Laser Skin Care
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arielle Kauvar, MD
Phone
212-249-9440
Email
info@nyskincare.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Efficacy and Safety of the triLift™ System

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