Prospective Clinical Study To Evaluate The Efficacy And Safety Of Paired Treatment With A Picosecond 755nm Alexandrite Laser With Focused Lens Array And Radiofrequency Microneedling For Facial Aging
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Wrinkle
- Sponsor
- Cynosure, Inc.
- Enrollment
- 42
- Locations
- 3
- Primary Endpoint
- Percent of Photos Identified Correctly of 30 Day Follow Up vs. Baseline
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The intended use of the radiofrequency and microneedling devices used in this study is to assess the efficacy and safety of paired treatment for the treatment of facial aging.
Detailed Description
Subjects are to be enrolled in this clinical study if they are a healthy male or female 40 - 65 years of age. Up to 35 subjects will be enrolled at 2 study centers. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 4 treatments on the face.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A healthy male or female between the age of 40 - 65 years old.
- •Diagnosed with clinically evident moderate wrinkles and/or moderate photoaging, including but not limited to dyschromia, and willing to undergo treatments with the study devices.
- •Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
- •Understands and accepts the obligation and is logistically able to be present for all visits.
- •Is willing to comply with all requirements of the study and sign the informed consent document.
Exclusion Criteria
- •The subject is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
- •The subject is hypersensitive to light in the near infrared wavelength region.
- •The subject is taking medication which is known to increase sensitivity to sunlight.
- •The subject has a seizure disorders triggered by light.
- •The subject is taking or have taken oral isotretinoin, such as Accutane®, within the last six months.
- •The subject has an active localized or systemic infection, or an open wound in area being treated.
- •The subject has a significant systemic illness, such as lupus, or an illness localized in area being treated.
- •The subject has active herpes simplex in the area being treated.
- •The subject is receiving or have received gold therapy.
- •The subject has a pacemaker.
Outcomes
Primary Outcomes
Percent of Photos Identified Correctly of 30 Day Follow Up vs. Baseline
Time Frame: 30 day follow up
The percent of correctly identified photographs (when comparing baseline photos vs. 30 day follow up photos) will be reported.
Percent of Photos Identified Correctly of 90 Day Follow Up vs. Baseline
Time Frame: 90 day follow up
The percent of correctly identified photographs (when comparing baseline photos vs. 90 day follow up photos) will be reported.