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

Status unconfirmed · Not applicable

Conditions studied: Wrinkle, Pigmented Lesions

In brief

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.

Key facts

Study ID

NCT04727099

Run by

Candela Corporation

People needed

50

Starts

2020-09-28

Expected to finish

2023-12-31

Last updated by the study team

2023-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Candela Institute of Excellence — Marlborough, Massachusetts, United States

Full record on ClinicalTrials.gov

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