This study will evaluate the use of the Lutronic PicoPlus for treatment of dermatological conditions such as unwanted tattoos and benign pigmented lesions.
This pilot clinical trial will evaluate the capability of the Lutronic PicoPlus technology to remove unwanted tattoos and benign pigmented lesions. This trial is designed as a multi-center exploratory, open-label clinical trial comparing each subject's condition before and after treatment. Subjects meeting all entrance criteria will be assigned to Group A for treatment of unwanted tattoos and Group B for treatment of unwanted benign pigmented lesions, melasma, or other skin conditions such as skin rejuvenation. Subjects in each treatment group will receive a series of treatments, e.g., 2-5, and will be asked to complete 1 and 3 month follow-up visit(s) following each treatment to assess treatment efficacy and safety. At investigators' discretion, additional follow-up visits, e.g., at 6 months following treatment, may take place to observe the time course of reactions after treatment and/or assess efficacy. Outcome measures include clinician grading and subject satisfaction post-treatment. Pre-treatment study photos will be obtained at baseline; post-treatment study photos will be obtained at each post-treatment follow-up visit.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Laser treatment using specific pulse durations and wavelengths for selective pigment photothermolysis.
Zena Medical
Newport Beach, California, United States
Metro Dermatology
Elmhurst, New York, United States
Laser and Skin Surgery Center of New York
New York, New York, United States
Dermatology, Laser, and Vein Specialists of the Carolinas
Charlotte, North Carolina, United States
Investigator's Global Assessment of Improvement
Overall aesthetic improvement based on completion of the Physician's Global Assessment of Improvement Scale. Physician evaluators will review study photos post-final treatment, and rate the degree of tattoo clearing or reduction in benign pigmentation observed in the subject's treated area using the following definitions: 3 = Very significant or complete clearing (75-100%) 2 = Significant clearing (50-74%) 1 = Moderate clearing (25-49%) 0 = Mild or no clearing (0-24%)
Time frame: Up to 6 Months following final study treatment
Subject's Global Assessment of Improvement
Overall aesthetic improvement based on completion of the Subject's Global Assessment of Improvement Scale. Subjects will be asked review study photos post-final treatment, and rate the degree of tattoo clearing or reduction in benign pigmentation observed in the subject's treated area using the following definitions: 3 = Very significant or complete clearing (75-100%) 2 = Significant clearing (50-74%) 1 = Moderate clearing (25-49%) 0 = Mild or no clearing (0-24%)
Time frame: 1 month, 3 Months, 6 Months (Group A Only) post final treatment
Subject Satisfaction
Following the final study treatment, subjects will be asked to rate their level of satisfaction with the laser treatment outcome and the overall laser treatment procedure, using the Subject Satisfaction Assessment Scale and the following definitions: 2 = Extremely Satisfied 1 = Satisfied 0 = Neutral (-1) = Unsatisfied (-2) = Extremely Unsatisfied
Time frame: 1 month, 3 Months, 6 Months (Group A Only) post final treatment
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