Lutronic Genius System for Neck Treatment
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|ClinicalTrials.gov Identifier: NCT03534609|
Recruitment Status : Completed
First Posted : May 23, 2018
Last Update Posted : January 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Wrinkle Skin Laxity Skin Texture Disorder||Device: Lutronic Genius System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, non-randomized, open label|
|Masking:||None (Open Label)|
|Official Title:||Exploratory Evaluation of the Lutronic Genius System for Treatment of the Neck|
|Actual Study Start Date :||March 27, 2018|
|Actual Primary Completion Date :||January 16, 2019|
|Actual Study Completion Date :||January 10, 2020|
Experimental: Genius System Neck Treatment
Lutronic Genius System treatment of lines, wrinkles, and texture concerns on the neck.
Device: Lutronic Genius System
Treatment of the neck using the Lutronic Genius System
- 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.
- Clinician aesthetic improvement [ Time Frame: From baseline to Days 90 following the last study treatment. ]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.
- Subject aesthetic improvement [ Time Frame: From baseline to Days 90 following the last study treatment. ]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.
- Patient Satisfaction [ Time Frame: From baseline to 90 days following the last study treatment ]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.
- Treatment-related pain [ Time Frame: For the duration of each study treatment which typically can last up to approximately 90 minutes. ]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'.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03534609
|United States, New York|
|Laser and Skin Surgery Center of New York|
|New York, New York, United States, 10016|
|Study Director:||Kari Larson, MBA||Sponsor GmbH|