NCT01796626

Clinical Evaluation of M22 ResurFX 1565nm Module

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Lumenis Be Ltd. · Industry
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

Summary

At least thirty (30) subjects, Fitzpatrick-Goldman Skin Type I-IV will be enrolled in 2 clinical sites; each clinic will enroll at least 15 subjects. Subjects should present visible wrinkles and/or striae requiring treatment. Hypothesis: The M22 ResurFX 1565nm module will improve the appearance of the wrinkles by at least 2 grades on the Fitzpatrick-Goldman Wrinkle and Elastosis Score, and striae by at least 50% using VAS as compared to baseline, for at least 75% of the subjects.

Conditions

• Wrinkles
• Striae

Interventions

Type	Name	Description
DEVICE	M22 ResurFX module	The system delivers pulsed near Infra-Red (NIR) laser light with a nominal wavelength of 1565 nm and has a unique treatment handpiece with epidermal cooling. The clinician is able to control the settings of energy, µBeams density, scan size, and shape option from the user interface (LCD GUI) display on the main M22 console.

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2013-02-22
• Last updated: 2014-08-26

Locations

2 sites across 1 country: United States