Face and Neck Wrinkles, Texture, PigmentationNCT03409965
Lutronic Infini and LaseMD Systems in Combination Treatment
A study testing Lutronic Infini System and Lutronic LaseMD System in people with Face and Neck Wrinkles, Texture, Pigmentation, run by CynosureLutronic at 2 sites in United States.
Trial summary
This is a prospective, multi-site, non-randomized study evaluating the safety and effectiveness of the Infini and LaseMD Systems for combination treatment in wrinkles, texture, and pigmentation of the face and/or neck. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Face and Neck Wrinkles, Texture, Pigmentation
- What is being tested?
- Lutronic Infini System and Lutronic LaseMD System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Dec 2017to 21 Aug 2018
- 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.
- Solar elastosis on the face and/or neck.
- Mild to moderate wrinkles of the face and/or neck.
- Mild to moderate textural concerns on the face and/or neck.
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- Sun and/or age-related pigmentation on the face and/or 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.
- Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
- Postmenopausal for at least 12 months prior to study;
- Without a uterus and/or both ovaries; or
- Bilateral tubal ligation at least six months prior to study enrollment.
- Absence of physical or psychological conditions unacceptable to the investigator.
- Willingness to refrain from use of aspirin, Ibuprofen, Naproxen, or any other NSAID prior to each study treatment and chronic use during the entire post-treatment study period. Washout period, if chronic user, for 4 weeks prior to the first treatment. After all study treatments are completed, limited acute NSAID use is allowed, i.e., a maximum of 2-3 doses in any 2-week period, if needed.
- 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 systemic or local skin disease that may affect wound healing.
- History of keloids or poor wound healing.
- Severe solar elastosis.
- Excessive subcutaneous fat in the area(s) to be treated.
- Excessive skin laxity on the area(s) to be treated.
- Significant scarring in the area(s) to be treated that would interfere with assessing results.
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- Open wounds or lesions in the area(s) to be treated.
- Inability to understand the protocol or to give informed consent.
- Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within four weeks prior to study participation or during the study.
- Excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
- BMI equal to or greater than 30.
- History of chronic drug or alcohol abuse.
- History of collagen vascular disease.
- History of autoimmune disease.
- Subjects with implanted pacemaker or defibrillator.
- Subjects with sensitivity or allergy to gold.
- Subjects with sensitivity or allergy to pre-treatment medication.
- Subjects with photosensitive skin.
- Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
- Subjects who anticipate the need for inpatient surgery or overnight hospitalization during the study.
- Subjects who, in the investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
- Concurrent enrollment in any study involving the use of investigational devices or drugs.
- Current smoker or history of smoking in the last five years.
- Current user of any nicotine-containing products, e.g., e-cigarettes, Nicorette gum, nicotine patches, etc.
- History of surgical or cosmetic treatments in the area(s) to be treated within the past year.
- History or current use of the following prescription medications:
- Accutane or other systemic retinoids within the past twelve months;
- Topical Retinoids within the past two weeks; and/or
- Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix) within the past two weeks.
- 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
2 sites in 1 country.
United States2 sites
The Aesthetic Clinique
Santa Rosa Beach, Florida, 32459
Moradi M.D.
Vista, California, 92083
About this study
Official title: Evaluation of the Lutronic Infini and Lutronic LaseMD Systems in Combination Treatment
This is a prospective, multi-site, non-randomized study evaluating the safety and effectiveness of the Infini and LaseMD Systems for combination treatment in wrinkles, texture, and pigmentation of the face and/or neck.
Read the detailed description
Enrolled subjects will receive three (3) face and/or neck treatments provided 30 days apart. During each treatment subjects will receive both Infini and LaseMD treatments. Treatments will be provided according to a protocol-specific treatment protocol in which an Infini treatment will be provided first, followed by a LaseMD treatment. A telephone contact will be completed at 3 days following each treatment to assess for adverse events. One follow-up visit will be conducted at 90 days following the last study treatment. Outcome measures include clinician grading and subject satisfaction post-treatment. Pre-treatment study photographs and D90 study photographs will be obtained.
- Being tested
- Lutronic Infini System, Lutronic LaseMD System
- Medical subject headings
- Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutronic Infini SystemDevice
A microneedle radiofrequency device
Lutronic LaseMD SystemDevice
A fractional thulium laser device
| Study group | Role | What they receive |
|---|---|---|
| Lutronic Systems Combination Treatment | Experimental | Combination treatment of the face and/or neck using the Lutronic Infini System and Lutronic LaseMD System. Receives: Device: Lutronic Infini System; Device: Lutronic LaseMD 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. Each blinded assessor will be given an identical set of baseline (pre-treatment) and Day 90 follow-up photos to be assessed. Each photo's visit interval, i.e., pre-treatment and follow-up, will NOT be marked. Each blinded assessor will conduct their assessment independently, comparing the Left and Right photos for improvement in the face and/or neck using the following definition:
- Change: An improvement that is:
- Striking, substantial and immediately noticeable, or
- Readily apparent but modest in nature
- Slight and subtle in nature, may require close examination
The assessor chooses the photo they believe to be the post-treatment photo, i.e., Left photo or Right photo.
Measured: 90 days following the last study treatment
Secondary outcomes (4)
Clinician assessment of overall aesthetic improvement
Overall aesthetic improvement based on completion of the Clinician Global Aesthetic Improvement Scale, a scale that rates global aesthetic improvement from the pretreatment appearance using the following definitions:
- = Improved: Improvement in appearance from initial condition
- = No Change: The appearance is essentially the same as the original condition
- = Worse: The appearance is worse than the original condition 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: 90 days following the last treatment.
Subject assessment of overall aesthetic improvement
Overall aesthetic improvement based on completion of the Subject Global Aesthetic Improvement Scale, a scale that rates global aesthetic improvement from the pretreatment appearance using the following definitions:
- = Improved: Improvement in appearance from initial condition
- = No Change: The appearance is essentially the same as the original condition
- = Worse: The appearance is worse than the original condition 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: 90 days following the last 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 photographs and their Day 90 follow-up photographs. Subjects will be asked to document Yes/No as to whether they notice any improvement in how their treated skin areas look; specify any changes they see in the treated areas, e.g., skin texture improvement, skin tone improvement, skin pigmentation improvement, etc.; characterize their level of satisfaction with study treatment based on 5 levels of satisfaction: Very satisfied, Satisfied, Slightly Satisfied, Neither Satisfied or Dissatisfied, Dissatisfied; document Yes/No if they would recommend the treatment to friends and family members.
Measured: 90 days following study treatment
Treatment-related pain
During study treatments, subjects' pain levels will be monitored using a validated Numeric Rating Scale (0-10), with 0 being 'No Pain' and 10 being the 'Worst Possible Pain'.
Measured: For the duration of each study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start8 Dec 2017
- Primary completion21 Aug 2018
- Study completion21 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Face and Neck Wrinkles, Texture, PigmentationStudies 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 study
- Masking
- None (open label)
- Enrolment
- 21 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
- NCT03409965
- Sponsor's protocol ID
- L17002
- Status last verified
- Aug 2018
- First submitted
- 17 Jan 2018
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Moradi A, Weiner SF. Effectiveness of Combining High-Intensity Focused Radiofrequency and Non-Ablative Fractional Laser for Improving the Appearance of the Aging Face and Neck. J Drugs Dermatol. 2019 Jan 1;18(1):59-64.
PubMed 30681798
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Lutronic Infini and Lutronic LaseMD Systems in Combination Treatment
- ClinicalTrials.gov ID
- NCT03409965
- Acronym / sponsor ID
- L17002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- CynosureLutronicIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- 21 Aug 2018 (actual)
- Study completion
- 21 Aug 2018 (actual)
- First posted
- 24 Jan 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.
This is a prospective, multi-site, non-randomized study evaluating the safety and effectiveness of the Infini and LaseMD Systems for combination treatment in wrinkles, texture, and pigmentation of the face and/or neck.
Detailed description
Enrolled subjects will receive three (3) face and/or neck treatments provided 30 days apart. During each treatment subjects will receive both Infini and LaseMD treatments. Treatments will be provided according to a protocol-specific treatment protocol in which an Infini treatment will be provided first, followed by a LaseMD treatment. A telephone contact will be completed at 3 days following each treatment to assess for adverse events. One follow-up visit will be conducted at 90 days following the last study treatment. Outcome measures include clinician grading and subject satisfaction post-treatment. Pre-treatment study photographs and D90 study photographs will be obtained.
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 study
| Arm | Type | Receives |
|---|---|---|
| Lutronic Systems Combination Treatment | Experimental | Device: Lutronic Infini System, Device: Lutronic LaseMD SystemCombination treatment of the face and/or neck using the Lutronic Infini System and Lutronic LaseMD System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male or female, age 18 years and older.
- Subject in good health.
- Fitzpatrick Skin Type I to VI.
- Solar elastosis on the face and/or neck.
- Mild to moderate wrinkles of the face and/or neck.
Key exclusion criteria (30 listed)
- Presence of an active systemic or local skin disease that may affect wound healing.
- History of keloids or poor wound healing.
- Severe solar elastosis.
- Excessive subcutaneous fat in the area(s) to be treated.
- Excessive skin laxity on the area(s) to be treated.
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 Infini SystemA microneedle radiofrequency device | Device | Lutronic Systems Combination Treatment |
| Lutronic LaseMD SystemA fractional thulium laser device | Device | Lutronic Systems Combination Treatment |
Primary outcome
Masked, qualitative assessment of improvement
Time frame: 90 days following the last study treatment
An assessment of paired pre- and post-treatment photographs will be conducted by blinded assessors. Each blinded assessor will be given an identical set of baseline (pre-treatment) and Day 90 follow-up photos to be assessed. Each photo's visit interval, i.e., pre-treatment and follow-up, will NOT be marked. Each blinded assessor will conduct their assessment independently, comparing the Left and Right photos for improvement in the face and/or neck using the following definition: * Change: An improvement that is: * Striking, substantial and immediately noticeable, or * Readily apparent but modest in nature * Slight and subtle in nature, may require close examination The assessor chooses the photo they believe to be the post-treatment photo, i.e., Left photo or Right photo.
4 secondary outcomes
Clinician assessment of overall aesthetic improvement
Time frame: 90 days following the last treatment.
Subject assessment of overall aesthetic improvement
Time frame: 90 days following the last treatment.
Patient Satisfaction
Time frame: 90 days following study treatment
Treatment-related pain
Time frame: For the duration of each study treatment
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 23 Aug 2018.
- Derived from this study: PubMed 30681798Moradi A, Weiner SF. Effectiveness of Combining High-Intensity Focused Radiofrequency and Non-Ablative Fractional Laser for Improving the Appearance of the Aging Face and Neck. J Drugs Dermatol. 2019 Jan 1;18(1):59-64.
- Individual participant dataSharing planned: Undecided
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lutronic Infini System and Lutronic LaseMD System in people with Face and Neck Wrinkles, Texture, Pigmentation, run by CynosureLutronic at 2 sites 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 17 inclusion and 30 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 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: 90 days following the last study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03409965, which also lists 1 linked publication.
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 23 Aug 2018.