Laxity of Skin
Conditions
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.
Interventions
DEVICEAuralevée device
Single treatment with Auralevée device.
Sponsors
Rocky Mountain Biosystems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed