Status:
UNKNOWN
Clinical Evaluation to Demonstrate the Safety and Performance of the Candela PicoWay System™
Lead Sponsor:
Candela Corporation
Conditions:
Wrinkle
Pigmented Lesions
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04727099
Start Date
September 28 2020
End Date
December 31 2023
Last Update
March 9 2023
Active Locations (1)
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1
Candela Institute of Excellence
Marlborough, Massachusetts, United States, 01752