Restylane Silk Microinjections to Cheeks

Silk for correction of mid to low cheek fine lines and wrinkles. Twenty (20) subjects will be
enrolled. Each subject will receive Restylane® Silk to the entire cheeks. The defined area
will be defined as the following: line extending from the upper margin of the nasal ala to
the upper margin of the tragus, from the tragus to 1 cm above the mandibular angle, from 1 cm
above the mandibular angle to 1 cm above the pre-jowl sulcus, and from 1 cm above the
pre-jowl sulcus to the upper margin of the nasal ala. The injections will be delivered
intradermally via multiple 0.02 cc microinjections distributed in a grid array pattern with
1-2 cm between each injection point (see figure 1; injections will extend 1 cm above the
illustration). Following completion of injection treatment, manual massage will be applied to
the full area to promote even distribution of the product. Each subject will undergo a total
of three treatment sessions, one month apart, day 1, week 4, and week 8. The maximum amount
of Restylane to be used per treatments session/per cheek is 1.5cc (not to exceed a total of 9
cc) per treated patient. Three-dimensional digital photography utilizing the Vectra 3D System
(Canfield) will be utilized to document pre-treatment status, sites of injection, and
post-treatment effect. Subjects will be followed up at 4 weeks, 8 weeks, post-treatment day
90, and day 180. Objective measures of efficacy will be me performed pre-treatment, at day 90
and 180.

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