Eligibility Details:
Inclusion Criteria:
b. Symmetrical visible sign of aging involving at least a 9 cm2 area of the mid to low
cheeks.
c. Must be willing to give and sign a HIPPA form, photo consent and informed consent form.
d. Must be willing to comply with study dosing and complete the entire course of the study.
e. Female patients will be either of non-childbearing potential defined as:
1. Having no uterus 2. No menses for at least 12 months. Or; (WOCBP) women of childbearing
potential must agree to use an effective method of birth control during the course of the
study, such as:
1. Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
2. Intrauterine coil
3. Bilateral tubal ligation
4. Barrier method used with an additional form of contraception (e.g., sponge, spermicide
or condom)
5. Abstinence (If practicing abstinence must agree to use barrier method described above
(4) if becomes sexually active).
6. Vasectomized partner (must agree to use barrier method described above (4) if becomes
sexually active with un-vasectomized).
f. Negative urine pregnancy test results Baseline prior to study entry (if applicable)
Exclusion Criteria:
1. Pregnant, planning pregnancy during the course of the study or breastfeeding
2. Extremely Severe aging face with extensive photodamage
3. Previous use of any form of soft tissue augmentation in the treatment area within
the past 12 months
4. Pre-existing medical or dermatologic condition in the treatment area that may
affect the treatment or interpretation of treatment effect (at investigator
discretion)
5. Presence of tattoo and/or scar in the treatment area that in the investigators
opinion would interfere with study assessments
6. Use of oral/topical retinoids within 1 month of Baseline
7. Previous use of botulinum toxins in the treatment area within the past 6 months
8. Previous surgical procedure in the treatment area within the past 12 months
9. Presence or evidence of any conditions that in the opinion of the investigator
might impede the subject's ability to give consent or comply with protocol
requirements.
10. Current participation or participation within 30 days prior to the start of this
study in a drug or other investigational research study
11. History of non-compliance with clinical research protocols
12. Ablative laser resurfacing to on their face within 12 months
13. Non-ablative laser or light procedures to their face within the past 3 months
14. Known allergy to Restylane® Silk or any of its constituents