NCT03456674

LaseMD System for the Treatment of Melasma

Evaluation of the Lutronic LaseMD System for the Treatment of Melasma

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: CynosureLutronic · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the clinical outcomes associated with use of the LaseMD Laser System for the treatment of melasma.

Detailed description

This clinical trial is a designed as a prospective, multi-site, non-randomized study of 20 subjects. Subjects will receive up to 5 study treatments completed 21 days apart. Phone follow-up will occur at Day 3 following each treatment for the assessment of adverse events and expected treatment effects. Post-treatment follow-up will be completed prior to the next subsequent treatment and at Days 30, 90 and 180 following the last treatment to assess adverse events and expected treatment effects, capture digital images, and assess efficacy.

Conditions

• Melasma

Interventions

Type	Name	Description
DEVICE	LaseMD System	A non-invasive fractional thulium laser delivering a wavelength of light energy as a fractionated array of microbeams to be absorbed by and damage the target molecule, a chromophore.

Timeline

• Start date: 2018-02-07
• Primary completion: 2019-05-31
• Completion: 2019-06-30
• First posted: 2018-03-07
• Last updated: 2019-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study