Lutronic LaseMD for Treatment of Benign Pigmented Lesions

Benign Pigmented Lesions Clinical Trial

Official title: Evaluation of the Lutronic LaseMD System for the Treatment of Benign Pigmented Lesions

Status Completed

Clinical Trial Summary

The Lutronic LaseMD Laser System will be evaluated for the treatment of benign pigmented lesions.

Clinical Trial Description

This clinical trial is a designed as a prospective, multi-site, non-randomized study of 20 subjects and two treatment groups. Subjects will be enrolled first into Group A, then Group B.

Group A: LaseMD 100 Tip Random Mode vs. DUAL 1927nm (n=12) Group A subjects will receive a split treatment of the décolleté, with LaseMD treatment on one side and DUAL 1927 treatment on the other side. Post-treatment follow-up visits (Days 4, 7, 14, 28, 90) will be conducted to assess adverse events, expected treatment effects, capture digital images, and assess efficacy.

Group B: LaseMD Optimized Treatments (n=8) Based on safety and efficacy data captured from Group A, subjects in Group B will be treated with the LaseMD optimized treatment parameters for benign pigmented lesions on décolleté, arms, hands, face, and/or neck. A phone follow-up will occur at Day 4 for the assessment of adverse events and expected treatment effects. Post-treatment follow-up visits (Days 4, 7, 14, 28, 90) will be conducted to assess adverse events, expected treatment effects, capture digital images, and assess efficacy. ;

Related Conditions & MeSH terms

• Benign Pigmented Lesions

• NCT number: NCT03409952
• Study type: Interventional
• Source: LUTRONIC Corporation
• Status: Completed
• Phase: N/A
• Start date: November 17, 2017
• Completion date: February 25, 2019