NCT04208100

Pilot Evaluation of the Lutronic PicoPlus System for the Treatment of Benign Pigmented Lesions of the Hands

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: CynosureLutronic · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Prospective, multi-site, non-randomized study of up to 40 treated subjects; subjects enrolled may be greater than subjects treated.

Detailed description

Subjects will be enrolled to ensure a minimum number of subjects by skin type participate in the study as follows: FST I-II, at least 5 subjects; FST III, at least 10 subjects; FST IV, at least 5 subjects. Additionally, up to 20 training subjects will be enrolled that will be excluded from efficacy analysis, but will be included in safety analysis. Standardized baseline and follow-up images will be taken using the sites' preferred camera system. No pre-treatment medication prior to study treatment. Phase I: Study subjects will receive up to three treatments with the PicoPlus with the 595nm on one hand and the 660nm on the other hand. Subjects will receive the same wavelength for all treatments on each specific hand; treatments will alternate by subjects between the left side getting treated with the 595nm and the right side getting treated with the 660nm depending on enrollment. Treatments will be 30+7 days apart up to three treatments until desired clearance has been achieved. Phase II: Up to 2 balancing treatments may be done if needed based on the investigator's discretion to achieve equal clearance on each hand utilizing the wavelength of the investigator's choice. Phase II will not be considered for efficacy endpoints.

Conditions

• Benign Pigmented Lesions

Interventions

Type	Name	Description
DEVICE	PicoPlus	The PICOPLUS Laser System (K173700) is indicated for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. The 595nm and 660nm wavelengths of the Lutronic PicoPlus Laser system are used for the treatment of benign pigmented lesions.

Timeline

• Start date: 2018-09-13
• Primary completion: 2019-09-05
• Completion: 2020-03-31
• First posted: 2019-12-23
• Last updated: 2019-12-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study