Jowls
Conditions
Brief summary
The objective of this study is to determine the effectiveness of a filler in improving wrinkles.
Detailed description
The primary objective of this study is to determine whether focal injection of calcium hydroxylapatite (Radiesse®), an injectable biodegradable filler, into jowl-induced chin notches can result in safe, aesthetically pleasing, and long-lasting correction of these.
Interventions
DEVICECalcium Hydroxylapatite injection
filler injection
Sponsors
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 40-65 * Have wrinkles * The subjects are in good health. * The subject has willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
Exclusion criteria
* Subjects who have received within the past 3 months or are planning to receive in the next 6 months, botulinum toxin injections for correction of wrinkles. * Subjects who have received within the past one year any soft tissue augmentation material into the chin and experimental area (defined as any area on the face below the lower lip vermilion, excluding the lateral lip marionette line up to 1 cm below this level). * Subjects with prior history of nodule formation or hypersensitivity reactions to lidocaine or medium-term augmentation materials, including hyaluronic acid derivatives, poly-L-lactic acid, and calcium hydroxylapatite. * Subjects who are currently using anticoagulation therapy. * Subjects who have a history of bleeding disorders. * Subjects who are unable to understand the protocol or to give informed consent. * Subjects with mental illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correction of wrinkles | 1 week |
Secondary
| Measure | Time frame |
|---|---|
| Development of adverse events | 1 week |
Outcome results
None listed