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

Wrinkle Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04727099
Study type Interventional
Source Candela Corporation
Contact
Status Active, not recruiting
Phase N/A
Start date September 28, 2020
Completion date December 31, 2023
View Details
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