WrinkleNCT03534609
Lutronic Genius System for Neck Treatment
A study testing Lutronic Genius System in people with Wrinkle and Skin Laxity, run by CynosureLutronic at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wrinkle, Skin Laxity, Skin Texture Disorder
- What is being tested?
- Lutronic Genius System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2018to 10 Jan 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, age 18 years and older.
- Subject in good health.
- Fitzpatrick Skin Type I to VI.
- Mild to moderate lines, wrinkles, textural concerns, and/or skin laxity of the neck.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
- 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.
Show all 10Show fewer
- Post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study.
- Absence of physical or psychological conditions unacceptable to the investigator.
- Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
- Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.
Who cannot join
- 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.
- History of skin disorders, keloid scarring, and/or abnormal wound healing.
- Open wounds or lesions in the area(s) to be treated.
- Inability to understand the protocol or to give informed consent.
- History of chronic drug or alcohol abuse.
- History of vascular disease.
Show all 20Show fewer
- History of bleeding disorders.
- BMI equal to or greater than 30.
- Subjects who are pregnant, nursing, or anticipate a pregnancy during the length of the trial.
- Subjects with current skin cancer or other malignant disease including pre-malignant moles.
- Poorly controlled medical condition that could compromise wound healing or increase risk of infection such as an impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications, radiation therapy, or chemotherapy.
- Subjects with implanted medical devices: pacemaker, cardioverts, superficial metal within the treatment area, and other implantable devices or synthetic fillers.
- Subjects with sensitivity or allergy to gold.
- Subjects with sensitivity or allergy to local anesthetics such as lidocaine or tetracaine.
- Concurrent enrollment in any study involving the use of investigational devices or drugs.
- History of surgical or cosmetic treatments in the area(s) to be treated within the past six months.
- History or current use of the following prescription medications:
- Daily anticoagulants, aspirin, iron supplements, herbal supplements such as ginkgo, ginseng or garlic within the past two weeks;
- Topical retinoid within the past one week; and
- Psychiatric drugs that in the investigators opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laser and Skin Surgery Center of New York
New York, New York, 10016
About this study
Official title: Exploratory Evaluation of the Lutronic Genius System for Treatment of the Neck
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.
- Conditions
- Wrinkle, Skin Laxity, Skin Texture Disorder
- Being tested
- Lutronic Genius System
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutronic Genius SystemDevice
Treatment of the neck using the Lutronic Genius System
| Study group | Role | What they receive |
|---|---|---|
| Genius System Neck Treatment | Experimental | Lutronic Genius System treatment of lines, wrinkles, and texture concerns on the neck. Receives: Device: Lutronic Genius System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 90 days following the last treatment
Secondary outcomes (4)
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.
Measured: From baseline to Days 90 following the last study treatment.
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.
Measured: From baseline to Days 90 following the last study treatment.
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.
Measured: From baseline to 90 days following the last study treatment
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'.
Measured: For the duration of each study treatment which typically can last up to approximately 90 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start27 Mar 2018
- Primary completion16 Jan 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies 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
- Model description
- Prospective, non-randomized, open label
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- CynosureLutronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kari Larson, MBA, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534609
- Sponsor's protocol ID
- L18000
- Status last verified
- Jan 2020
- First submitted
- 16 Apr 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Evaluation of the Lutronic Genius System for Treatment of the Neck
- ClinicalTrials.gov ID
- NCT03534609
- Acronym / sponsor ID
- L18000
- Conditions
- Wrinkle, Skin Laxity, Skin Texture Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- CynosureLutronicIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 16 Jan 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 23 May 2018 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-randomized, open label
| Arm | Type | Receives |
|---|---|---|
| Genius System Neck Treatment | Experimental | Device: Lutronic Genius SystemLutronic Genius System treatment of lines, wrinkles, and texture concerns on the neck. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, age 18 years and older.
- Subject in good health.
- Fitzpatrick Skin Type I to VI.
- Mild to moderate lines, wrinkles, textural concerns, and/or skin laxity of the neck.
- Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
Key exclusion criteria (20 listed)
- 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.
- History of skin disorders, keloid scarring, and/or abnormal wound healing.
- Open wounds or lesions in the area(s) to be treated.
- Inability to understand the protocol or to give informed consent.
- History of chronic drug or alcohol abuse.
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 |
|---|---|---|
| Lutronic Genius SystemTreatment of the neck using the Lutronic Genius System | Device | Genius System Neck Treatment |
Primary outcome
Masked qualitative assessment of improvement
Time frame: From baseline to 90 days following the last treatment
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.
4 secondary outcomes
Clinician aesthetic improvement
Time frame: From baseline to Days 90 following the last study treatment.
Subject aesthetic improvement
Time frame: From baseline to Days 90 following the last study treatment.
Patient Satisfaction
Time frame: From baseline to 90 days following the last study treatment
Treatment-related pain
Time frame: For the duration of each study treatment which typically can last up to approximately 90 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
Related trials for Wrinkle
Enrolling by invitation
Efficacy of an LED Mask
Fine Lines and Wrinkles, Skin Health
Not yet recruiting
Effects of Probiotics on Skin Health in Healthy Women
Skin Aging, Dry Skin
Not yet recruiting
Evaluation of MD60002 Device for Facial Skin Aging
Facial Wrinkles, Skin Aging
Recruiting
Evaluation of the Performance and Safety of the MD60000 Device in the Treatment of Skin Imperfections Due to Aging.
Skin Aging
Recruiting
Clinical Evaluation of a Multi-functional Beauty Device on Cosmetic Skin Outcomes
Skin Appearance, Skin Texture
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.
Kari Larson, MBA study director
Sponsor GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lutronic Genius System in people with Wrinkle and Skin Laxity, run by CynosureLutronic 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 10 inclusion and 20 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: finished, as of the sponsor's last update on 13 Jan 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Masked qualitative assessment of improvement (time frame: From baseline to 90 days following the last treatment). 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 13 Jan 2020.