Evaluation of Efficacy and Safety of the triLift™ System

Wrinkle Clinical Trial

— LUM-triLift  

Official title:

Evaluation of Efficacy and Safety of the triLift™ System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05773924
• Other study ID #: LUM-ABU-triLift-22-01
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2023
• Est. completion date: August 15, 2023

Study information

• Verified date: February 2023
• Source: Lumenis Be Ltd.
• Contact: Fiona Kerr
• Phone: 212-249-9440
• Email: nurses[@]nylaserskincare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cutis Laxa
• Skin Laxity
• Wrinkle

Intervention

Device:
• triLift system
To evaluate the efficacy of the triLift™ treatment

Locations

Country	Name	City	State
United States	NY Laser Skin Care	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Lumenis Be Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months
Secondary	3D images	Measuring facial lifting using 3D imaging and analysis algorithm from Quantificare before and after the treatment protocol	4 months
Secondary	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	3 months
Secondary	Subject level of Satisfaction	Subject satisfaction will be assessed using a 5 level satisfaction questionnaire.	4 months