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This study is intended to demonstrate the safety and efficacy of the PicoWayâ„¢ 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 PicoWayâ„¢ 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benign Pigmented Lesions | Experimental | Up to six (6) treatments with PicoWay laser for treatment of benign pigmented lesions |
|
| Wrinkles | Experimental | Up to six (6) treatments with PicoWay laser for treatment of wrinkles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PicoWay Laser System | Device | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation Adverse Events | Incidence, severity, and relatedness of adverse events. Severity is rated on a scale from 0 to 4 where 0 = none and 4 = severe | through study completion, approximately 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Candela Institute of Excellence | Marlborough | Massachusetts | 01752 | United States |
No IPD plan.
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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" |
| 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 |