ClinicalTrials.gg
CompletedNCT03534609Updated Jan 13, 2020

Lutronic Genius System for Neck Treatment

An interventional study of Lutronic Genius System in Wrinkle, Skin Laxity and Skin Texture Disorder, sponsored by LUTRONIC Corporation. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-13.

Sponsored by LUTRONIC Corporation (part of Cynosure Lutronic, Inc.) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jan 2019, 7 years 9 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The Genius system is substantially equivalent to the Infini device (K121481). The study is a prospective, multi-site, non-randomized study of up to 30 treated subjects presenting for treatment of mild to moderate lines, wrinkles, textural concerns, and/or skin laxity of the neck.

Read the detailed description

At enrollment, standardized baseline/pretreatment 2D and 3D images will be obtained from each subject. Study subjects will receive three neck treatments completed 30 days apart. Subjects will be contacted via a phone call 3 days following each treatment to assess for adverse events and expected treatment effects. Effectiveness assessments will occur prior to Treatments #2 and #3, and a follow-up visit will be completed at 90 days following Treatment #3. Each assessment visit will include efficacy, adverse events, and expected treatment effects assessments, and post-treatment 2D and 3D digital images will be captured.

02

Conditions studied

  • Wrinkle
  • Skin Laxity
  • Skin Texture Disorder
03

In context

Lead sponsor

LUTRONIC Corporation is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

First submitted before LUTRONIC Corporation became part of Cynosure Lutronic, Inc..

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female, age 18 years and older.
  2. Subject in good health.
  3. Fitzpatrick Skin Type I to VI.
  4. Mild to moderate lines, wrinkles, textural concerns, and/or skin laxity of the neck.
  5. Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
  6. Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
  7. , surgically sterilized, or using a medically acceptable form of at least 3 months prior to enrollment and during the entire course of the study.
  8. Absence of physical or psychological conditions unacceptable to the investigator.
  9. Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
  10. Willingness and ability to provide written and HIPAA authorization prior to performance of any study-related procedure.

Exclusion criteria

Exclusion Criteria:

  1. Presence of an active skin condition or infection in the treatment area such as sores, Psoriasis, eczema, rash, severe active inflammatory acne or oral herpes simplex breakout.
  2. History of skin disorders, keloid scarring, and/or abnormal wound healing.
  3. Open wounds or lesions in the area(s) to be treated.
  4. Inability to understand the protocol or to give .
  5. History of chronic drug or alcohol abuse.
  6. History of vascular disease.
  7. History of bleeding disorders.
  8. equal to or greater than 30.
  9. Subjects who are pregnant, nursing, or anticipate a pregnancy during the length of the trial.
  10. Subjects with current skin cancer or other malignant disease including pre-malignant moles.
  11. Poorly controlled medical condition that could compromise wound healing or increase risk of infection such as an impaired immune system due to diseases such as AIDS and , or use of immunosuppressive medications, radiation therapy, or chemotherapy.
  12. Subjects with implanted medical devices: pacemaker, cardioverts, superficial metal within the treatment area, and other implantable devices or synthetic fillers.
  13. Subjects with sensitivity or allergy to gold.
  14. Subjects with sensitivity or allergy to local anesthetics such as lidocaine or tetracaine.
  15. Concurrent enrollment in any study involving the use of devices or drugs.
  16. History of surgical or cosmetic treatments in the area(s) to be treated within the past six months.
  17. History or current use of the following prescription medications:

    1. Daily anticoagulants, aspirin, iron supplements, herbal supplements such as ginkgo, ginseng or garlic within the past two weeks;
    2. Topical retinoid within the past one week; and
    3. Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Genius System Neck Treatment

    Lutronic Genius System treatment of lines, wrinkles, and texture concerns on the neck.

    Device: Lutronic Genius System

Interventions

  • DeviceLutronic Genius System

    Treatment of the neck using the Lutronic Genius System

06

What researchers measure

Primary outcomes

  1. Masked qualitative assessment of improvement

    An assessment of paired pre- and post-treatment photographs will be conducted by blinded assessors evaluating for improvement in neck appearance from pre- to post-treatment. The assessors choose the photo they believe to be the post-treatment photo, i.e., Left photo or Right photo.

    Time frame: From baseline to 90 days following the last treatment

Secondary outcomes

  1. Clinician aesthetic improvement

    Overall aesthetic improvement based on completion of the Clinician Global Aesthetic Improvement Scale, a 5-point scale (0-4) that rates global aesthetic improvement from the pre-treatment appearance with 4 being 'Very Much Improved' and 0 being 'Worse'. The scale will be administered based on a live assessment of the subject while referring to the subject's pre-treatment photographs, and based on a comparison of the subject's pre-treatment photographs to the Day 90 follow-up photographs.

    Time frame: From baseline to Days 90 following the last study treatment.

  2. Subject aesthetic improvement

    Overall aesthetic improvement based on completion of the Subject Global Aesthetic Improvement Scale, a 5-point scale (0-4) that rates global aesthetic improvement from the pre-treatment appearance with 4 being 'Very Much Improved' and 0 being 'Worse'. Subjects will complete the scale based on a live assessment while referring to a hand mirror and their pre-treatment photographs, and based on a comparison of their pre-treatment photographs to their Day 90 follow-up photographs.

    Time frame: From baseline to Days 90 following the last study treatment.

  3. Patient Satisfaction

    Patient satisfaction will be evaluated based on subjects' completion of a patient satisfaction questionnaire while referring to a hand mirror and their pre-treatment and their Day 90 follow-up photographs.

    Time frame: From baseline to 90 days following the last study treatment

  4. Treatment-related pain

    During each study treatment, subjects' pain levels will be monitored using a validated Numeric Rating Scale (0-10), with 0 being 'No Pain' and 10 being 'Worse Possible Pain'.

    Time frame: For the duration of each study treatment which typically can last up to approximately 90 minutes.

07

Study locations

1 site
  • Laser and Skin Surgery Center of New York
    New York, New York 10016, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2018 to primary completion in Jan 2019, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 16, 2018
First posted
May 23, 2018
StartActual
Mar 27, 2018
Primary completionActual
Jan 16, 2019
CompletionActual
Jan 10, 2020
Last update
Jan 13, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03534609
Responsible party
Sponsor
First posted
May 23, 2018
Start date
Mar 27, 2018
Primary completion
Jan 16, 2019
Completion
Jan 10, 2020
Last update
Jan 13, 2020

Study contacts

Kari Larson, MBA
study director · Sponsor GmbH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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