Investigation of Radiofrequency Device for Treatment of Wrinkles and Rhytides
Not Applicable
Completed
- Conditions
- Laxity of Skin
- Registration Number
- NCT01279226
- Lead Sponsor
- Rocky Mountain Biosystems, Inc.
- Brief Summary
The purpose of this pilot research study is to collect information on the safety and effectiveness of an experimental device intended to be used to improve the appearance of the skin by reducing the visibility of wrinkles and by reducing the looseness of skin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- Male or female at least 21 years old,
- Apparently healthy,
- Informed consent signed by the subject.
Exclusion Criteria
- Tobacco smokers,
- History of skin hypersensitivity,
- Current skin disorder or infection (e.g., herpes simplex),
- Prior cosmetic treatments to the face (e.g. Botox) or facial fillers (e.g. Restylane),
- Subjects with a pacemakers, internal defibrillators or electronically, magnetically, and mechanically activated implants,
- Subjects with implanted medical prostheses (such as clips, pins or plates) proximal to the treatment site,
- The current or recent use (within the past 12 months) of isotretinoin,
- Pregnancy or breast feeding,
- Insulin dependent diabetic subjects,
- Oxygen dependent subjects,
- Subjects with severe chronic illness, scleroderma, or lupus,
- Subjects with open sores or scars in the treatment region, or
- Subjects with ischemia in the treatment region.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Improved cosmesis 2-6 timepoints from 4 days to 6 months Photographs of subjects before and after treatment will be scored and compared. Histology of skin samples may be used to assess deleterious events and elucidate the operative mechanism.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Laser Treatment Center
🇺🇸Kirkland, Washington, United States