PicoWay™ 730 Resolve Fusion for Benign Pigmented Lesions and Wrinkles

Not Applicable

Completed

Interventions: Device: PicoWay™ 532nm fractional handpiece
Device: PicoWay™ 1064nm fractional handpiece
Device: PicoWay™ 730nm wavelength

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

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
PicoWay™ 730nm wavelength	PicoWay™ 532nm fractional handpiece	PicoWay™ 730nm wavelength. Subjects will receive up to four study treatments with the PicoWay™ 730nm wavelength.
PicoWay ™1064nm fractional handpiece	PicoWay™ 1064nm fractional handpiece	Subjects will receive up to four study treatments with the PicoWay™ 1064nm fractional handpiece
Picoway™ 532nm fractional handpiece	PicoWay™ 730nm wavelength	Subjects will receive up to four study treatments with the PicoWay™ 532nm fractional handpiece

Primary Outcome Measures

Name	Time	Method
Change in Wrinkles From Baseline to 12 Weeks Post-study Treatment Assessed by Blinded Photographic Evaluation Using 9-Point Fitzpatrick Wrinkle Scale	Baseline to 12-week follow-Up Visit	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)
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	Baseline to 12-week follow-Up Visit	5-Point Pigment Clearance Score (Score, Clearance %, Description) 1. = 0-24% = Poor Response 2. = 25-49% = Fair Response 3. = 50-74% = Good Response 4. = 75-94% = Excellent Response 5. = \>95% = CompleteResponse

Secondary Outcome Measures

Name	Time	Method
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	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	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.