Clinical Evaluation to Demonstrate the Safety and Performance of the Candela PicoWay System™
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Wrinkle
- Sponsor
- Candela Corporation
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Benign Pigmented Lesions (BPLs) and Global Aesthetic Improvement Score (GAIS)
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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).
Investigators
Eligibility Criteria
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) \>/=
- •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
Outcomes
Primary Outcomes
Benign Pigmented Lesions (BPLs) and Global Aesthetic Improvement Score (GAIS)
Time Frame: 12 months
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."
Benign Pigmented Lesions (BPLs) and Pigment Improvement Score (PIS)
Time Frame: 12 months
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"
Wrinkles and Global Aesthetic Improvement Score (GAIS) 3 month follow up
Time Frame: 12 months
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."
Wrinkles and Fitzpatrick Wrinkle and Elastosis Score 3 month follow up
Time Frame: 12 months
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".
Secondary Outcomes
- BPLs and Global Aesthetic Improvement Score (GAIS) 1 month follow up(10 months)
- BPLs and PIS 3 month follow up(10 months)
- Wrinkles and Fitzpatrick Wrinkle and Elastosis Score 1 month follow up(10 months)
- Wrinkles and Global Aesthetic Improvement Score (GAIS) 1 month follow up(10 months)
- Overall Subject Satisfaction 3 month follow up(12 months)