785nm Picosecond Laser for Treatment of Benign Pigmented Lesions

Benign Pigmented Lesions Clinical Trial

Official title: Clinical Study to Evaluate the Performance of the PicoWay 1064 nm/ 785 nm/ 532nm Picosecond Laser for Treatment of Benign Pigmented Lesions

Status Recruiting

Clinical Trial Summary

This is an open-label, multi-center study. Subjects in this study will receive up to eight (8) treatments in 11±5 weeks (6-16 weeks) interval, with the PicoWay device using the 785 nm wavelength alone or combined with 1064 nm or 532 nm wavelengths. Subjects will return for one follow‐up (FU) visit at the clinic at 8 weeks following the last treatment.

Clinical Trial Description

This study is a prospective clinical study to demonstrate the safety and efficacy of the PicoWay device for benign pigmented lesion treatment.

Up to a total of 60 healthy candidates, who are seeking treatment/clearance of benign pigmented lesions, will be enrolled at up to 3 participating study sites. Subjects will receive up to eight (8) PicoWay treatments at 11±5 (6-16) week's intervals. Prior to each consecutive treatment, the investigator will decide, based on degree of clearance assessment, should the subject undergo additional treatment or proceed to the 8-weeks follow-up (FU) visit with no more treatments. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Pigmented Lesions

• NCT number: NCT02891239
• Study type: Interventional
• Source: Syneron Medical
• Contact: Konika Schallen, MD
• Phone: 508-358-7400
• Email: konikap@syneron.com
• Status: Recruiting
• Phase: N/A
• Start date: September 2016
• Completion date: September 2017