Exploratory Evaluation of the Lutronic Genius System for Treatment of the Neck
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- LUTRONIC Corporation
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Masked qualitative assessment of improvement
Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
- •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.
Exclusion Criteria
- •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.
- •History of bleeding disorders.
- •BMI equal to or greater than
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Subject aesthetic improvement(From baseline to Days 90 following the last study treatment.)
- Clinician aesthetic improvement(From baseline to Days 90 following the last study treatment.)
- Patient Satisfaction(From baseline to 90 days following the last study treatment)
- Treatment-related pain(For the duration of each study treatment which typically can last up to approximately 90 minutes.)