Restylane Silk Microinjections to Cheeks

A Single Center, Prospective, Open-label, Clinical Trial Using Micro-injections of Transparent Hyaluronic Acid Gel (Restylane® Silk) for Rejuvenation of the Aging Cheek

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.

Study Overview

• Status: Unknown
• Conditions: Wrinkle
• Intervention / Treatment: Device: Restylane® Silk

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shannon Quigley; Phone Number: 141 858 657 1004; Email: SQuigley@CLDerm.com

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Recruiting
      • West Dermatology Research Center
      • Contact: Kristi Cobb; Phone Number: 139 858-657-1004; Email: KCobb@CLDerm.com
      • Contact: Isabella Guiha; Phone Number: 119 858 657 1004; Email: IGuiha@CLDerm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyaluronic Acid Microinjection	Device: Restylane® Silk; Injectable Hyaluronic Acid (HA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator five point global aesthetic improvement score	Change in Investigator five point global aesthetic improvement score from Baseline at all follow up visits through month 6 using Investogator's Global Aesthetic Improvement Scale	Baseline to 6 - Months Post Final Treatment
Cutometer Measured Skin Elaticity	Change in elasticity from baseline to the last visit measured using a Cutometer	Baseline to 6 - Months Post Final Treatment
Hydrometer measured Transepidermal Water Loss	Change in transepidermal waterloss from baseline to the last visit measured using a hydrometer.	Baseline to 6 - Months Post Final Treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Injection Site Adverse Events	At each follow up visit, any adverse effects such as but not limited to bruising, erythema, swelling, pain, tenderness, itching, dysesthesia, and nodularity will be recorded descriptively.	Baseline to 6 - Months Post Final Treatment

Collaborators and Investigators

• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 1, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Silkcheek-2018-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No