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

Lumenis

Status

Enrolling

Conditions

Skin Laxity

Wrinkle

Treatments

Device: triLift system

Study type

Interventional

Funder types

Industry

Identifiers

NCT05773924

LUM-ABU-triLift-22-01

Details and patient eligibility

About

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

Full 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.

Enrollment

25 estimated patients

Sex

All

Ages

35 to 55 years old

Volunteers

Accepts 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.