Clinical Evaluation to Demonstrate the Safety and Performance of the Candela PicoWay System™

Study Overview
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Brief Summary
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This study is intended to demonstrate the safety and efficacy of the PicoWay™ Laser System for its intended uses: clearance of benign pigmented lesions and improvement in appearance of wrinkles.

Detailed Description
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This is a prospective, non-randomized, open-label study evaluating the safety and efficacy of the PicoWay™ Laser System for its intended uses: clearance of benign pigmented lesions and improvement in appearance of wrinkles. Up to 200 eligible participants will be enrolled at up to five (5) sites. Participants will receive up to 6 treatments to the face and/or off-face locations with treatment intervals of 4 weeks +/- 2 weeks. Participants will complete follow-up visits for clinical evaluation and photography at 1 and 3 months after the final treatment. Total study duration is approximately 12 months (up to 9 months for treatment and 3 months for follow up).

Official Title
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Clinical Evaluation to Demonstrate the Safety and Performance of the Candela PicoWay System™

Conditions
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Wrinkle, Pigmented Lesions

Intervention / Treatment
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* Device: PicoWay Laser System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age or older Willingness to provide signed, informed consent to participate in the study Presence of mild or greater benign pigmented lesions, and/or wrinkles assessed as Fitzpatrick Wrinkle and Elastosis Score (FWS) >/= 1. Willingness to adhere to study treatment and follow-up schedule Willingness to adhere to post-treatment care instructions Willingness to allow photographs and/or video of treated areas, and to release their use for scientific/educational and/or promotional/marketing purposes Willing to abstain from any other procedures, medications or topicals in the study treatment areas for the duration of the study which the investigator deems would interfere with the study Exclusion Criteria: Pregnant, planning pregnancy during the study, or breast feeding Tattooed skin in the intended treatment area unless tattoo removal treatment is to be performed. Active sun tan in the intended treatment area History of active Herpes Virus Simplex (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication History of melanoma History of vitiligo in the intended treatment area History of keloid or hypertrophic scar formation History of Melasma in the intended treatment area per Investigator's discretion Use of systemic retinoid therapy (e.g. Accutane) during the past 6 months 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 The subject is not suitable, in the opinion of the Investigator, for participation in the study due to inability to adhere to the study requirements, medical, or other reasons that could compromise the study integrity or subject safety Dermatologic and/or cosmetic procedures including use of medications, or topicals in the intended treatment area(s) during a timepoint prior to the study that the investigator deems the subject unsuitable for the study

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Benign Pigmented Lesions<br>Up to six (6) treatments with PicoWay laser for treatment of benign pigmented lesions | Device: PicoWay Laser System<br>* The PicoWay® laser system is an alexandrite laser pumped, solid-state Neodymium:Yttruium Aluminum Garnet (Nd:YAG) laser emitting energy at user selectable wavelengths of 1064 nm, 532 nm, 785 nm or 730 nm, designed for the treatment of tattoo, benign pigmented lesions, acne scars, and wrinkles.<br>|
| Experimental: Wrinkles<br>Up to six (6) treatments with PicoWay laser for treatment of wrinkles | Device: PicoWay Laser System<br>* The PicoWay® laser system is an alexandrite laser pumped, solid-state Neodymium:Yttruium Aluminum Garnet (Nd:YAG) laser emitting energy at user selectable wavelengths of 1064 nm, 532 nm, 785 nm or 730 nm, designed for the treatment of tattoo, benign pigmented lesions, acne scars, and wrinkles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Benign Pigmented Lesions (BPLs) and Global Aesthetic Improvement Score (GAIS) | Improvement in Benign Pigmented Lesions (BPLs) from Baseline to 3 Month follow-up (= 12 months maximum) via the Investigator Global Aesthetic Improvement Score (IGAIS) where 5 = worse, and 1 = very much improved. | 12 months | 
| Benign Pigmented Lesions (BPLs) and Pigment Improvement Score (PIS) | Improvement in Benign Pigmented Lesions (BPLs) from Baseline to 3 Month follow-up (= 12 months maximum) via the Pigment Improvement Score (PIS) where a score of 0 = no improvement and a score of 4 = Excellent response: Most or all lesions much lighter or gone | 12 months | 
| Wrinkles and Global Aesthetic Improvement Score (GAIS) 3 month follow up | Improvement in the appearance of wrinkles from Baseline 3 Month follow-up (= 12 months maximum) via the Investigator Global Aesthetic Improvement Score (IGAIS) where 5 = worse, and 1 = very much improved. | 12 months | 
| Wrinkles and Fitzpatrick Wrinkle and Elastosis Score 3 month follow up | Improvement in the appearance of wrinkles from Baseline 3 Month follow-up (= 12 months maximum) via the Investigator Fitzpatrick Wrinkle and Elastosis Scale where a score of 1 = fine wrinkles or mild elastosis and 9 = deep wrinkles or severe elastosis. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BPLs and Global Aesthetic Improvement Score (GAIS) 1 month follow up | Improvement in BPLs from Baseline to 1 Month follow-up (= 10 months maximum) via the Investigator Global Aesthetic Improvement Score (IGAIS) where 5 = worse, and 1 = very much improved. | 10 months | 
| BPLs and PIS 3 month follow up | Improvement in BPLs from Baseline to 1 Month follow-up (= 10 months maximum) via the Pigment Improvement Score (PIS) where a score of 0 = no improvement and a score of 4 = Excellent response: Most or all lesions much lighter or gone | 10 months | 
| Wrinkles and Fitzpatrick Wrinkle and Elastosis Score 1 month follow up | Improvement in the appearance of wrinkles from Baseline to 1 Month follow-up (= 10 months maximum) via the Investigator Fitzpatrick Wrinkle and Elastosis Scale where a score of 1 = fine wrinkles or mild elastosis and 9 = deep wrinkles or severe elastosis. | 10 months | 
| Wrinkles and Global Aesthetic Improvement Score (GAIS) 1 month follow up | Improvement in the appearance of wrinkles from Baseline to 1 Month follow-up (= 10 months maximum) via the Investigator Global Aesthetic Improvement Score (IGAIS) where 5 = worse, and 1 = very much improved. | 10 months | 
| Overall Subject Satisfaction 3 month follow up | Overall subject satisfaction with study treatments per treatment indication as measured by Subject Satisfaction Scale and Subject Global Aesthetic Improvement Score (SGAIS). (Baseline to 3 month follow up, approximately 12 months) | 12 months |