Restylane Silk Microinjections to Cheeks
Restylane Silk Microinjections to Cheeks
The objective of this study is to determine the efficacy and safety of Restylane® Silk
 microinjections when used in a grid-like injection pattern for the correction of fine lines
 to the 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