NCT05773924

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

March 17, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

February 23, 2023

Last Update Submit

March 6, 2023

Conditions

Skin LaxityWrinkle

Keywords

laxity, facial lifting, wrinkles, rhytids

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 3D images

    4 months

  • Comfort assessment

    3 months

  • Subject level of Satisfaction

    4 months

Study Arms (1)

Trilift system treatment arm

OTHER

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

Device: triLift system

Interventions

triLift systemDEVICE

To evaluate the efficacy of the triLift™ treatment

Trilift system treatment arm

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NY Laser Skin Care

New York, New York, 10028, United States

RECRUITING

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Arielle Kauvar, MD

    New York Laser & Skin Care

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiona Kerr

CONTACT

212-249-9440nurses@nylaserskincare.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 17, 2023

Study Start

February 10, 2023

Primary Completion

August 15, 2023

Study Completion

August 15, 2023

Last Updated

March 17, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)