Clinical trial NCT05773924: Evaluation of Efficacy and Safety of the triLift™ System
Official title: Evaluation of Efficacy and Safety of the triLift™ System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Laxity
Wrinkle
Keywords: laxity, facial lifting, wrinkles, rhytids
Lead sponsor: Lumenis Be Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-17
Enrollment: 25
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Global Aesthetic Improvement scale (GAI)
timeFrame: 4 months
Secondary outcomes:
measure: 3D images
timeFrame: 4 months
measure: Comfort assessment
timeFrame: 3 months
measure: Subject level of Satisfaction
timeFrame: 4 months
Other outcomes:
Locations:
city: New York
country: United States
facility: NY Laser Skin Care
state: New York
Study officials:
affiliation: New York Laser & Skin Care
name: Arielle Kauvar, MD
role: PRINCIPAL_INVESTIGATOR
References: