The Lutronic LaseMD Laser System will be evaluated for the treatment of benign pigmented lesions.
This clinical trial is a designed as a prospective, multi-site, non-randomized study of 20 subjects and two treatment groups. Subjects will be enrolled first into Group A, then Group B. Group A: LaseMD 100 Tip Random Mode vs. DUAL 1927nm (n=12) Group A subjects will receive a split treatment of the décolleté, with LaseMD treatment on one side and DUAL 1927 treatment on the other side. Post-treatment follow-up visits (Days 4, 7, 14, 28, 90) will be conducted to assess adverse events, expected treatment effects, capture digital images, and assess efficacy. Group B: LaseMD Optimized Treatments (n=8) Based on safety and efficacy data captured from Group A, subjects in Group B will be treated with the LaseMD optimized treatment parameters for benign pigmented lesions on décolleté, arms, hands, face, and/or neck. A phone follow-up will occur at Day 4 for the assessment of adverse events and expected treatment effects. Post-treatment follow-up visits (Days 4, 7, 14, 28, 90) will be conducted to assess adverse events, expected treatment effects, capture digital images, and assess efficacy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Laser treatment of benign pigmented lesion based on photothermolysis whereby the target molecule, the chromophore, absorbs a delivered wavelength of light over a period of time to damage the target while limiting collateral damage to adjacent structures, leading to pigmentary clearance.
Laser treatment of benign pigmented lesion using optimized treatment settings.
Maryland Dermatology Laser, Skin & Vein Institute
Hunt Valley, Maryland, United States
Dermatology, Laser, and Vein Specialists of the Carolinas
Charlotte, North Carolina, United States
Group A: Evaluation of split-side pigmentary clearance
Blinded assessment of paired post-treatment study photographs conducted by three blinded physician evaluators will compare split-side post-treatment photos. Each assessor will be given identical paired post-treatment photo sets. Each photo's treatment device (LaseMD or DUAL 1927nm) will NOT be marked. Each assessor will compare the Left and Right photo for improvement in benign pigmented lesions using the following definitions: Change = an improvement that is striking, substantial and immediately noticeable; readily apparent but modest in nature; or slight and subtle in nature. The photo believed to be the most improved photo (Left photo or Right photo) is selected.
Time frame: 90 days following the last study treatment
Group B: Percentage of pigmentary clearance in standard photographs
Blinded assessment of paired study photographs conducted by three blinded physician assessors will compare pre- and post-treatment photos. Each assessor will compare paired photo sets for percentage of pigmentary clearance using a score of 0-4: 0=poor (0-24%), 1=fair (25-49%), 2=good (50-74%), 3=excellent (75-95%), 4=complete (95%+) improvement. Each assessor will be given identical paired pre- and post-treatment photo sets. Each photo's visit interval (pre and post treatment) will NOT be marked. Each assessor will compare Left and Right photo for improvement in benign pigmented lesions using the following definitions: * Change = an improvement that is striking, substantial and immediately noticeable; readily apparent but modest in nature; or slight and subtle in nature. The photo believed to be the post-treatment photo (Left photo or Right photo) is selected. The assessor will then score the percentage of pigmentary clearance using the 0-4 scale.
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. Split-side assessments will be conducted for Group A subjects. 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 current post-treatment photographs. Aesthetic improvement will be based on 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.
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Time frame: 28 and 90 days following study treatments
Subject assessment of overall aesthetic improvement
Overall aesthetic improvement based on completion of the Subject Global Aesthetic Improvement Scale. Split-side assessments will be conducted for Group A subjects. Subjects will complete the scale based on a live assessment referring to a hand mirror and their pre-treatment photographs, and based on a comparison of their pre-treatment photographs to the current post-treatment photographs. Aesthetic improvement will be based on 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.
Time frame: 28 and 90 days following study treatments
Patient Satisfaction Questionnaire
Based on completion of a Patient Satisfaction Questionnaire while referring to a hand mirror and their pre-treatment photographs. Group A subjects will be asked to complete the questionnaire based on a split-side assessment providing responses specific to each treatment side, i.e., LaseMD treated and DUAL 1927mm treated. Patients will be asked to provides responses to document the level of improvement in skin pigment using the following categories of improvement: 75-100% improved, 50-74% improved, 25-49% improved, 0-24% improved; document any other improvements noted, e.g., skin texture improvement, skin tone improvement, fine lines and wrinkles improvement, etc.; characterize their level of satisfaction based on the following levels of satisfaction: Very Satisfied, Satisfied, Slightly Satisfied; Neither Satisfied or Dissatisfied, Dissatisfied; document if they would recommend each treatment to friends and family members.
Time frame: 90 days following study treatment
Treated-related pain
During study treatment, 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'. The average pain score for each device will be recorded. Group A will be split-side assessments.
Time frame: For the duration of each study treatment