Recruiting

triLift™ System

Sponsor:

Lumenis Be Ltd.

Code:

NCT05773924

Conditions

Skin Laxity

Wrinkle

Eligibility Criteria

Sex: All

Age: 35 - 55

Healthy Volunteers: Accepted

Interventions

triLift system

Study Details

Brief summary:

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

Conditions

Skin Laxity

Wrinkle

Study ID

NCT05773924

Start date

Feb 10, 2023

Status verified date

Feb, 2023

Completion date

Aug 15, 2023

Anticipated

Primary completion date

Aug 15, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 55

Healthy Volunteers: Accepted

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

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Trilift system treatment arm

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

Interventions

triLift system

To evaluate the efficacy of the triLift™ treatment

Primary outcome measure

  • The Global Aesthetic Improvement scale (GAI) [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Fiona Kerr

212-249-9440nurses@nylaserskincare.com

Locations

NY Laser Skin Care

Recruiting

New York, New York, United States, 10028

Contacts

Arielle Kauvar, MD

212-249-9440info@nyskincare.com

More Information

Sponsor

Lumenis Be Ltd.

Last update posted

Mar 17, 2023

Last verified

Feb, 2023

Keywords

  • laxity, facial lifting, wrinkles, rhytids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lumenis Be Ltd. on 2023-03-17.