Completed
Treatment of Periorbital and Perioral Wrinkles With the Applications of the Iluminage Diode Laser
What is being tested
Illuiminage ® Diode Laser
Device
Who is being recruted
From 35 to 60 Years
+18 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: November 2012
Summary
Principal SponsorCynosure, Inc.
Last updated: March 26, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2012
Actual date on which the first participant was enrolled.The Diode laser system is being used in this marketing study for the treatment of wrinkles around the eyes and mouth.
Principal SponsorCynosure, Inc.
Last updated: March 26, 2014
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Female
Biological sex of participants that are eligible to enroll.From 35 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
5 inclusion criteria required to participate
Subjects who are healthy females between 35 and 60 years of age
Subjects who are willing and able to comply with study instructions and to return to the clinic for required visits and have photographs of their face taken
Subjects who have Fitzpatrick skin type I-VI
Subjects who have perioral and periorbital wrinkles, as deemed appropriate by the Investigator or his designees
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13 exclusion criteria prevent from participating
Subject's use of oral isotretinoin (Accutane) within 12 months of initial laser application or during the course of the study
Subjects ever having facial skin treatments with home use laser, light based or radiofrequency or other devices, i.e. PaloVia or Tria
Subjects having had facial skin treatments with any professional laser, light based, radiofrequency or other devices within the last year
Subjects who are unwilling to maintain their daily skin care regimen for the duration of the study
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalDiode laser to treat peri-orbital and peri-oral wrinkles
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center