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This study will evaluate the use of the Lutronic PicoPlus for treatment of dermatological conditions such as unwanted tattoos and benign pigmented lesions.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or Female
Adults between age 18 and 60 years old
Group A: Fitzpatrick skin type I - VI for unwanted tattoos and Group B: Fitzpatrick Skin Types I - IV for benign pigmented lesions and other conditions
Unwanted tattoo that contains single or multi-color ink, and
Ability to read, understand, and sign the Informed Consent Form
Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, educational or marketing purposes.
Understands and accepts the obligation not to undergo any other procedures in the areas to be treated
Willing and able to comply with all study participation requirements including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
39 participants in 2 patient groups
There are currently no registered sites for this trial.
Start date
Oct 12, 2017 • 7 years ago
End date
Sep 06, 2018 • 6 years ago
Results posted
ViewDec 20, 2023 • 1 year and 4 months ago
Today
May 06, 2025
Lead Sponsor
Data sourced from clinicaltrials.gov
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