Lutronic PicoPlus Exploratory Clinical Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of the Lutronic PicoPlus for the Treatment of Dematological Conditions Such as Unwanted Tattoos and Benign Pigmented Lesions

Conditions
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Tattoo; Pigmentation, Melasma, Benign Pigmented Lesion

Intervention / Treatment
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* Device: PicoPlus laser system


Participation Criteria
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Eligibility Criteria
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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 Wiling to cover tattoos with a bandage or clothing; and/or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated area starting 2 to 4 weeks before the treatment 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: If receiving treatment for unwanted tattoo: double tattoos (tattoo over tattoo), history of allergic reactions to pigments following tattooing, local anesthetics or topical antibiotics If receiving treatment for benign pigmented lesions including melasma: history of use of a lightening medication (hydroquinone, tranexamic acid), isotretinoid (or retinoid), or light-sensitive medication in the last 6 months Known cardiovascular disease or cardiac surgery that in the opinion of the investigator would interfere with study treatments Previous interventions or treatment with another device in the target area within 6 months of enrollment or during the study Pregnant or lactating or planning pregnancy before end of study Presence of an active systemic, local skin disease, medication or condition that may affect wound healing or interfere with participation or treatment to the active area. Active or recurrent cancer of current chemotherapy or radiation therapy History of seizure disorders due to light History of vitiligo, eczema, or psoriasis History of connective tissue disease, such as systemic lupus erythematosus or scleroderma History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen History of keloid scarring, hypertrophic scarring or of abnormal wound healing. History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications. History of seizure disorders due to light. Suffering from coagulation disorders or taking prescription anticoagulation medications History of keloid scarring, hypertrophic scarring or of abnormal wound healing Any use of medication that is known to increase sensitivity to light according to Investigator's discretion Excessive or recent significant tan in areas to be treated or unable/unlikely to refrain from tanning during the study Current smoker or history of smoking within 3 months of study participation Systemic use of corticosteroid or isotretinoin within 6 months of study participation Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus Any physical or mental condition including alcohol or drug abuse that in the opinion of the investigator could interfere with subject's suitability for inclusion in study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be assigned to one of two treatments group depending on the dermatologic condition to be treated.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A: PicoPlus for unwanted tattoos.<br>Subjects receiving PicoPlus laser system treatment for unwanted tattoos. | Device: PicoPlus laser system<br>* Laser treatment using specific pulse durations and wavelengths for selective pigment photothermolysis.<br>|
| Active Comparator: Group B: PicoPlus for other dermatological conditions<br>Subjects receiving PicoPlus laser system treatment for unwanted benign pigmented lesions, melasma or other dermatological conditions such as skin rejuvenation. | Device: PicoPlus laser system<br>* Laser treatment using specific pulse durations and wavelengths for selective pigment photothermolysis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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%) | Up to 6 Months following final study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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%) | 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 | 1 month, 3 Months, 6 Months (Group A Only) post final treatment |