Skin LaxityLUM-triLiftNCT05773924
Evaluation of Efficacy and Safety of the triLift™ System
A study testing triLift system in people with Skin Laxity and Wrinkle, run by Lumenis Be Ltd. at 1 site in United States.
Trial summary
Single center, single-arm, prospective, open Label with Before \& After Study Design. Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity, Wrinkle
- What is being tested?
- triLift system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2023to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
NY Laser Skin Care
New York, New York, 10028
Arielle Kauvar, MD, 212-249-9440, info@nyskincare.com
About this study
Single center, single-arm, prospective, open Label with Before \& After Study Design.
Read the 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.
- Conditions
- Skin Laxity, Wrinkle
- Being tested
- triLift system
- Keywords
- laxity, facial lifting, wrinkles, rhytids
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triLift systemDevice
To evaluate the efficacy of the triLift™ treatment
| Study group | Role | What they receive |
|---|---|---|
| Trilift system treatment arm | Other | Single arm with Before \& After photos, triLift treatment protocol study design. Receives: Device: triLift system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (3)
3D images
Measuring facial lifting using 3D imaging and analysis algorithm from Quantificare before and after the treatment protocol
Measured: 4 months
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
Measured: 3 months
Subject level of Satisfaction
Subject satisfaction will be assessed using a 5 level satisfaction questionnaire.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start10 Feb 2023
- Primary completion15 Aug 2023 (estimated)
- Study completion15 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lumenis Be Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arielle Kauvar, MD, Principal investigator, New York Laser & Skin Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773924
- Sponsor's protocol ID
- LUM-ABU-triLift-22-01
- Acronym
- LUM-triLift
- Status last verified
- Feb 2023
- First submitted
- 23 Feb 2023
- Last updated
- 17 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of the triLift™ System
- ClinicalTrials.gov ID
- NCT05773924
- Acronym / sponsor ID
- LUM-triLift / LUM-ABU-triLift-22-01
- Conditions
- Skin Laxity, Wrinkle
- Keywords
- laxity, facial lifting, wrinkles, rhytids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Lumenis Be Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trilift system treatment arm | Other | Device: triLift systemSingle arm with Before \& After photos, triLift treatment protocol study design. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| triLift systemTo evaluate the efficacy of the triLift™ treatment | Device | Trilift system treatment arm |
Primary outcome
The Global Aesthetic Improvement scale (GAI)
Time frame: 4 months
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.
3 secondary outcomes
3D images
Time frame: 4 months
Comfort assessment
Time frame: 3 months
Subject level of Satisfaction
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arielle Kauvar, MD principal investigator
New York Laser & Skin Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing triLift system in people with Skin Laxity and Wrinkle, run by Lumenis Be Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fiona Kerr (212-249-9440, nurses@nylaserskincare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Global Aesthetic Improvement scale (GAI) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.