PicoWay™ 730 Resolve Fusion for Benign Pigmented Lesions and Wrinkles

Study Overview
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Brief Summary
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Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for Treatment of Benign Pigmented Lesions and Wrinkles.

Detailed Description
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Subjects will receive up to 4 study treatments with the PicoWay™ 730 nm laser wavelength, PicoWay™1064nm fractional handpiece and/or PicoWay™ 1064nm fractional handpiece for treatment of benign pigmented lesions or wrinkles. Subjects will return for three follow-up visit evaluations 1-month, 2-months and 3-months post final study treatment. Primary efficacy assessed by masked photographic evaluation. Optional biopsy collection for histological analysis of laser tissue effects.

Official Title
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Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for Treatment of Benign Pigmented Lesions and Wrinkles

Conditions
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Benign Pigmented Lesions, Facial Wrinkles

Intervention / Treatment
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* Device: PicoWay™ 532nm fractional handpiece
* Device: PicoWay™ 730nm wavelength
* Device: PicoWay™ 1064nm fractional handpiece


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Willing to provide signed informed consent Adults age 21 to 80 Fitzpatrick Skin Type (FST) I to VI Presence of benign pigmented Lesions assessed at baseline as Pigment Severity Score (PSS) of 2 or higher and/or wrinkles assessed at baseline as Fitzpatrick Wrinkle Score (FWS) of 2 or higher Willing to allow photographs and/or video to be taken of treated areas for the purposes of this research study Willing to abstain from any other procedures for treatment of benign pigmented lesions or wrinkles in the laser treatment areas for the duration of the study including surgery, light, laser, ultrasound or radiofrequency treatments Willing to abstain from use of prescription cosmetic products for treatment of benign pigmented lesions or wrinkles in the laser treatment areas for the duration of the study including injections of neurotoxins or dermal fillers, skin lightening creams, and wrinkle creams Willingness to adhere to study treatment and follow-up visit schedules Exclusion Criteria Pregnant, planning pregnancy or breast feeding Allergy to topical or injectable lidocaine or similar medications Allergy to topical steroid or similar medications Unprotected sun exposure in the six weeks prior to enrollment, or active tan in the laser treatment area History of melanoma in the intended treatment area History of keloid or hypertrophic scar formation Use of topical or systemic retinoid therapy during the past six (6) months Use of neurotoxins in the intended treatment area within the past three (3) months or throughout the duration of the study Use of dermal fillers in the intended treatment area within the last six (6) months or throughout the duration of the study Severe immunosuppression resulting from medications and/or a medical condition that could impair healing after treatment. Open wound or infection in the intended treatment area History of light induced seizure disorders Dermatologic and/or cosmetic procedures in the intended treatment area(s) during the past six months The subject is not suitable, in the opinion of the clinician, for participation in the study due to medical or other reasons that could compromise the study integrity or subject safety

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Picoway™ 532nm fractional handpiece<br>Subjects will receive up to four study treatments with the PicoWay™ 532nm fractional handpiece | Device: PicoWay™ 730nm wavelength<br>* PicoWay™ Laser System is picosecond 532/1064/785 laser<br>|
| Experimental: PicoWay™ 730nm wavelength<br>PicoWay™ 730nm wavelength. Subjects will receive up to four study treatments with the PicoWay™ 730nm wavelength. | Device: PicoWay™ 532nm fractional handpiece<br>* PicoWay™ Laser System is picosecond 532/1064/785 laser<br>|
| Experimental: PicoWay ™1064nm fractional handpiece<br>Subjects will receive up to four study treatments with the PicoWay™ 1064nm fractional handpiece | Device: PicoWay™ 1064nm fractional handpiece<br>* PicoWay™ Laser System is picosecond 532/1064/785 laser<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Wrinkles From Baseline to 12 Weeks Post-study Treatment Assessed by Blinded Photographic Evaluation Using 9-Point Fitzpatrick Wrinkle Scale | 9-Point Fitzpatrick Wrinkle Scale (FWS) 1=Fine Wrinkles to 9=Deep Wrinkles 1-3 Mild (fine textural changes with subtly accentuated skin lines) 4-6 Moderate (distinct papular elastosis [individual papules with yellow translucency under direct lighting] and dyschromia) 7-9 Severe (multipapular and confluent elastosis [thickened yellow and pallid] approaching or consistent with cutis rhomboidalis) | Baseline to 12-week follow-Up Visit | 
| Change in Benign Pigmented Lesions From Baseline to 12 Weeks Post-study Treatment in Pigment Clearance Score (PCS) as Determined by Blinded Evaluators From Clinical Photography | 5-Point Pigment Clearance Score (Score, Clearance %, Description) = 0-24% = Poor Response = 25-49% = Fair Response = 50-74% = Good Response = 75-94% = Excellent Response = >95% = CompleteResponse | Baseline to 12-week follow-Up Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Subject Satisfaction Mean of Scores From 2nd Treatment Visit to Last Visit by Treatment Group Using a 5-Point Likert-type Rating Scale | During the 2nd Treatment Visit and all subsequent study visits (treatment and follow-up), Subject Satisfaction Surveys were obtained from all subjects. The scale used to evaluate subject satisfaction is a Likert-type rating Scale and follows -2, -1, 0, 1, 2 for responses of Extremely Dissatisfied, Somewhat Dissatisfied, Neither Satisfied nor Dissatisfied, Somewhat Satisfied and Extremely Satisfied respectfully. The scores are stratified according to treatment group. | Pre-Treatment 2 at Week 6, Pre-Treatment 3 at Week 12, Pre-Treatment 4 at Week 18, 1 Month Follow-Up at Week 22, 2 Month Follow-Up at Week 26, and 3 Month Follow-Up at Week 30 |