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

Benign Pigmented Lesions Clinical Trial

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

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Benign Pigmented Lesions

• NCT number: NCT04208100
• Study type: Interventional
• Source: LUTRONIC Corporation
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 13, 2018
• Completion date: March 31, 2020