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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
A microneedle radiofrequency device
A fractional thulium laser device
Moradi M.D.
Vista, California, United States
The Aesthetic Clinique
Santa Rosa Beach, Florida, United States
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.
Time frame: 90 days following the last study treatment
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: 1. = Improved: Improvement in appearance from initial condition 2. = No Change: The appearance is essentially the same as the original condition 3. = 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.
Time frame: 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: 1. = Improved: Improvement in appearance from initial condition 2. = No Change: The appearance is essentially the same as the original condition 3. = 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.
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Time frame: 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.
Time frame: 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'.
Time frame: For the duration of each study treatment