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.
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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Candela Institute of Excellence
Marlborough, Massachusetts, United States
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."
Time frame: 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"
Time frame: 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."
Time frame: 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".
Time frame: 12 months
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."
Time frame: 10 months
BPLs and PIS 3 month follow up
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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"
Time frame: 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".
Time frame: 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."
Time frame: 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)
Time frame: 12 months