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Clinical Evaluation of M22 ResurFX 1565nm Module

NCT01796626 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2014-08-26

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Lumenis Be Ltd.

    lead INDUSTRY

Principal Investigators

  • Mitchel P Goldman, MD · DCLA

  • Arielle NB Kauvar, MD · New York Laser & Skin Care

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01796626 on ClinicalTrials.gov