NCT03409952

Lutronic LaseMD for Treatment of Benign Pigmented Lesions

Evaluation of the Lutronic LaseMD System for the Treatment of Benign Pigmented Lesions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: CynosureLutronic · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Benign Pigmented Lesions

Interventions

Type	Name	Description
DEVICE	LaseMD and DUAL 1927nm Laser	Laser treatment of benign pigmented lesion based on photothermolysis whereby the target molecule, the chromophore, absorbs a delivered wavelength of light over a period of time to damage the target while limiting collateral damage to adjacent structures, leading to pigmentary clearance.
DEVICE	LaseMD	Laser treatment of benign pigmented lesion using optimized treatment settings.

Timeline

• Start date: 2017-11-17
• Primary completion: 2018-12-20
• Completion: 2019-02-25
• First posted: 2018-01-24
• Last updated: 2019-03-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study