785nm Picosecond Laser for Treatment of Benign Pigmented Lesions

Study Overview
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Brief Summary
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This is an open-label, multi-center study. Subjects in this study will receive up to eight (8) treatments in 11±5 weeks (6-16 weeks) interval, with the PicoWay device using the 785 nm wavelength alone or combined with 1064 nm or 532 nm wavelengths. Subjects will return for one follow-up (FU) visit at the clinic at 8 weeks following the last treatment.

Detailed Description
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This study is a prospective clinical study to demonstrate the safety and efficacy of the PicoWay device for benign pigmented lesion treatment. Up to a total of 60 healthy candidates, who are seeking treatment/clearance of benign pigmented lesions, will be enrolled at up to 3 participating study sites. Subjects will receive up to eight (8) PicoWay treatments at 11±5 (6-16) week's intervals. Prior to each consecutive treatment, the investigator will decide, based on degree of clearance assessment, should the subject undergo additional treatment or proceed to the 8-weeks follow-up (FU) visit with no more treatments.

Official Title
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Clinical Study to Evaluate the Performance of the PicoWay 1064 nm/ 785 nm/ 532nm Picosecond Laser for Treatment of Benign Pigmented Lesions

Conditions
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Benign Pigmented Lesions

Intervention / Treatment
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* Device: PicoWay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy female and male subjects between 18 to 70 years of age Fitzpatrick skin type I-VI Presence of unwanted benign pigmented lesions including but not limited to solar lentigines, freckles, café au lait, melasma, Nevis of Ota, Nevus of Ito and hyperpigmentation. Multiple lesions can be treated. Willing to receive the proposed PicoWay treatments and comply with all study (protocol) requirements to remove unwanted benign pigmented lesions. Willing to have photographs and images taken of the treated areas to be used in evaluations, publications and presentations (subject identity will be masked). For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence) Informed consent process is completed and subject consent is signed. Exclusion Criteria: Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding Hypersensitivity to light exposure Taking medication(s) for which sunlight is a contraindication Active sun tan Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course History of squamous cell carcinoma or melanoma History of keloid scarring, abnormal wound healing and / or prone to bruising Use of oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment, e.g., lack of noticeable skin flaking, skin peeling and skin surface roughness History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications Known allergy to lidocaine, tetracaine, Xylocaine or epinephrine Has had a laser procedure, a peel or has used lightening creams in the area to be treated with in the past six months Subjects with pigmented lesions that are considered not acceptable by the study doctor or any condition that, in the study doctor's opinion, would make it unsafe to treat As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PicoWay laser treatment<br>3 wavelength tattoo treatment with picosecond laser (PicoWay) | Device: PicoWay<br>* solid state laser capable of delivering energy at wavelengths of 1064 nm or 532 nm or wavelength of 785 nm that was added to the system<br>* Other names: PicoWay device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blinded evaluation of pigmentation clearance | Global percentage of pigmentation clearance, as assessed by blinded evaluators based on comparing pre and post treatment photos. | 8 weeks post final treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global percentage of pigmentation clearance | Global percentage of pigmentation clearance, as assessed by study investigators based on comparing pre and post treatment photos. | 8 weeks post final treatment | 
| Number of patients with adverse events | Based on rate and severity of treatments with the PicoWay laser treatment | Through study completion, average of 1 year | 
| Investigator satisfaction with treatment | A 5-point satisfaction scale will be used by study investigators to assess satisfaction with treatment outcome | 8 weeks post final treatment | 
| Subject satisfaction with treatment | A 5-point satisfaction scale will be used by subjects to assess satisfaction with treatment outcome | 8 weeks post final treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laser treatment