NCT03409965

Lutronic Infini and LaseMD Systems in Combination Treatment

Evaluation of the Lutronic Infini and Lutronic LaseMD Systems in Combination Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: CynosureLutronic · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, multi-site, non-randomized study evaluating the safety and effectiveness of the Infini and LaseMD Systems for combination treatment in wrinkles, texture, and pigmentation of the face and/or neck.

Detailed description

Enrolled subjects will receive three (3) face and/or neck treatments provided 30 days apart. During each treatment subjects will receive both Infini and LaseMD treatments. Treatments will be provided according to a protocol-specific treatment protocol in which an Infini treatment will be provided first, followed by a LaseMD treatment. A telephone contact will be completed at 3 days following each treatment to assess for adverse events. One follow-up visit will be conducted at 90 days following the last study treatment. Outcome measures include clinician grading and subject satisfaction post-treatment. Pre-treatment study photographs and D90 study photographs will be obtained.

Conditions

• Face and Neck Wrinkles, Texture, Pigmentation

Interventions

Type	Name	Description
DEVICE	Lutronic Infini System	A microneedle radiofrequency device
DEVICE	Lutronic LaseMD System	A fractional thulium laser device

Timeline

• Start date: 2017-12-08
• Primary completion: 2018-08-21
• Completion: 2018-08-21
• First posted: 2018-01-24
• Last updated: 2018-08-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study