Wrinkles and Rhytides
Conditions
Brief summary
In this study we propose to test the Biofusionary Bebe in order to reduce skin laxity and improve contour and cosmesis.
Interventions
DEVICEBiofusionary Bebe
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 65 Years
Healthy volunteers
Yes
Inclusion criteria
The inclusion criteria for the study are: * Male or female 21 to 65 years old, * Clinically appreciable skin laxity on the abdomen (including flank), face, neck, hips, thighs, upper arms & buttocks as determined by the study investigator, * For females, post-menopausal, surgically sterilized, or using a medically accepted form of birth control for at least 3 months prior to the study, * Apparently healthy, * Informed consent signed by the subject.
Exclusion criteria
The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in cosmesis | 1 month | Improvement in cosmesis will be assessed by scoring photographs taken before and 1 month after treatment. Circumference changes will be measured and compared |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in cosmesis | 3 months | Improvement in cosmesis will be assessed by scoring photographs taken before and at 3 months after treatment. Circumference changes will be measured and compared. |
Countries
United States
Outcome results
None listed