Evaluate the Performance of the PicoWayTM Picosecond Fractional Laser for Wrinkles Reduction

Study Overview
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Brief Summary
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Prospective clinical study, Up to 100 healthy adult volunteers seeking Treatment of Wrinkles Reduction in the facial area, males or females of 18 to 75 years of age, from up to 5 investigational sites.

Detailed Description
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This is an open-label, multi-center study. Subjects in this study will receive up to four (4) facial treatments in 3-8 weeks interval, with the PicoWayTM device-fractional hand piece 1064nm and/or 532nm according to the study protocol. Subjects will be followed by phone 7 days post first treatment by study staff, and will return for follow-up (FU) visits at the clinic at: 6 weeks and 12 weeks following the last treatment. Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.

Official Title
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Clinical Study to Evaluate the Performance of the PicoWayTM Picosecond Fractional Laser for Wrinkles Reduction

Conditions
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Unwanted Wrinkles

Intervention / Treatment
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* Device: PicoWayTM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy female and male subjects between 18 to 75 years of age Has Fitzpatrick skin type I-VI Subjects seeking treatment for wrinkles reduction and willing to undergo laser treatments for improvement Have mild to moderate bilateral perioral and/or periorbital wrinkles Willing to receive the proposed PicoWayTM fractional treatments and comply with all study (protocol) requirements 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 Active sun tan in facial area 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 Is taking medication(s) for which sunlight is a contraindication Has a history of squamous cell carcinoma or melanoma History of keloid scarring, abnormal wound healing and / or prone to bruising History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders Has used 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. A laser procedure, a peel or has used lightening creams that was performed in the area to be treated with the past six months History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications Known allergy to lidocaine, tetracaine, Xylocaine or epinephrine Subjects with pigmented lesions that are considered not acceptable by the study investigator or any condition that, in the investigator'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: 75 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: all subjects<br>will receive up to four (4) facial treatments in 3-8 weeks interval, with the PicoWayTM device-fractional hand piece 1064nm and/or 532nm according to the study protocol. Subjects will be followed by phone 7 days post first treatment by study staff, and will return for follow-up (FU) visits at the clinic at: 6 weeks and 12 weeks following the last treatment. | Device: PicoWayTM<br>* The PicoWayTM base unit using a single, free-running, flashlamp-pumped alexandrite laser as a pump source for both the oscillator and the amplifier<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of PicoWay for facial wrinkles reduction treatment assessed by blinded evaluators based on Fitzpatrick Classification and Degree of Elastosis. | assessed by blinded evaluators. | day 0 up to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Fitzpatrick Classification and Degree of Elastosis, as assessed by study investigator | Percentage of subjects with improvement in Fitzpatrick Classification and Degree of Elastosis, as assessed by study investigator | from 3 weeks up to 9 months | 
| Safety of PicoWay treatment by Adverse events record during all study | assessed by study investigator during all study | day 0 up to 9 months | 
| Evaluate investigator satisfaction assessed by questionnaire | by questionnaire | from 24 weeks up to 36 weeks | 
| Evaluate subject satisfaction assessed by questionnaire | by questionnaire | from 24 weeks up to 36 weeks |