| Eligibility |
Inclusion Criteria:
- 1. Outpatient, male or non-pregnant, non-nursing females, at least 22 years of age,
and in good general health.
2. Subject willing to abstain from other aesthetic procedures on the head or face
including receiving other dermal fillers, laser treatments, use of any product that
affects skin remodeling, or a product that may cause an active dermal response in the
treatment area from screening through the last study follow-up visit.
3. Female subjects of childbearing potential must have a negative urine pregnancy test
result at the Treatment Visit, prior to product administration.
4. Able to understand the requirements of the trial and sign informed consent
including authorization to release health information.
5. Subject willing and able to comply with study follow-up procedures and schedule.
6. Subject willing to provide written informed consent for their participation in the
study including authorization to release health information.
Exclusion Criteria:
- 1. Subject is a female of childbearing potential (e.g., not postmenopausal for at
least one year or has not had a hysterectomy or tubal ligation) not using medically
effective birth control (e.g., hormonal methods such as birth control pills; implants;
Intrauterine Device (IUDs), etc., in use at least 30 days prior to injection or
barrier methods such as condom and spermicide in use at least 14 days prior to
injection), or is pregnant, lactating, or plans to become pregnant during the study.
2. Subject has participated in a clinical study in which an investigational device or
drug was received in the 30 days prior to screening or plans to enroll in such a study
during the course of the current study.
3. Subject is an employee or direct relative of an employee of the investigational
site or Sponsor.
4. Subject has a serious or progressive disease, which, in the investigator's
judgment, puts the subject at undue risk (e.g., uncontrolled diabetes, autoimmune
pathology, cardiac pathologies).
5. Subject has a local acute inflammatory process or infection, or history of chronic
or recurrent infection or inflammation with the potential to interfere with the study
results or increase the risk of adverse events.
6. Subject has a disorder that may impact wound healing such as connective tissue or
immunosuppressive disorder.
7. Subject has had an active skin disease in the treatment area within the past 6
months.
8. Subject has scars, infection, rosacea, herpes, acne, blotches or other pathology
behind the ears. Subject is predisposed to keloidosis or hypertrophic scarring.
9. Subject has known allergy to hyaluronic acid, 1,4-butanediol diglycidyl ether
(BDDE), gram-positive bacterial proteins or streptococcal proteins.
10. Subject has history of hypersensitivity to local anesthetics of the amide type,
such as lidocaine.
11. Subject has severe allergies as manifested by a history of anaphylaxis, or a
history or presence of multiple severe allergies.
12. Subject has a known bleeding disorder. 13. Subject has received or plans to
receive within 1 week prior to injection through 1 week following or in the one week
prior to 30 day biopsy through 1 week after any treatment/procedure that may impact
coagulation such as high-dose Vitamin E, aspirin, anti-inflammatories, antiplatelets,
thrombolytics, or any other medication that could increase the risk of bleeding.
Subject has received within the past 3 months or plans to receive during the study
chemotherapy agents, immunosuppressive medications, or systemic corticosteroids
(inhaled steroids are acceptable).
14. Subject has received within the past 12 months or plans to receive during the
study any treatment or procedure involving the post-auricular area.
15. Any condition or situation which, in the Investigator's opinion, puts the subject
at significant risk, could confound the trial results, or may interfere significantly
with the subject's participation in the trial.
|
