Micro-injections of Transparent Hyaluronic Acid Gel (Restylane® Silk) for Rejuvenation of the Aging Cheek

NCT03461198 | Unknown FDA Device

• 1 other identifier: Restylane Silk Microinjections
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wrinkle

Outcome Measures

Primary Outcomes (1)

• Efficacy

  Improvement on a validated 9-point Goldman-Fitzpatrick Wrinkle Scale (GFWS)

  Baseline to Day 180 post treatment

Study Arms (1)

Treatment

EXPERIMENTAL

Restylane® Silk to a defined area of mid to low cheeks.

Device: Restylane® Silk

Interventions

Restylane® Silk DEVICE

Restylane® Silk to a defined area of mid to low cheeks

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female in general good health age 18 or over.
• Mild to moderate static rhytids involving at least a 9 cm2 area of the mid to low cheeks.
• Must be willing to give and sign a HIPPA form, photo consent and informed consent form.
• Must be willing to comply with study dosing and complete the entire course of the study.
• Female patients will be either of non-childbearing potential defined as:
• Having no uterus
• 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:
• Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
• Intrauterine coil
• Bilateral tubal ligation
• Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
• Abstinence (If practicing abstinence must agree to use barrier method described above (4) if becomes sexually active).
• Vasectomized partner (must agree to use barrier method described above (4) if becomes sexually active with un-vasectomized).
• Negative urine pregnancy test results Baseline prior to study entry (if applicable)

You may not qualify if:

• Pregnant, planning pregnancy during the course of the study or breastfeeding
• Severe static rhytids to the mid to low cheeks
• Previous use of any form of soft tissue augmentation in the treatment area within the past 12 months
• Pre-existing medical or dermatologic condition in the treatment area that may affect the treatment or interpretation of treatment effect (at investigator discretion)
• Presence of tattoo and/or scar in the treatment area that in the investigators opinion would interfere with study assessments
• Use of oral/topical retinoids within 1 month of Baseline
• Previous use of botulinum toxins in the treatment area within the past 6 months
• Previous surgical procedure in the treatment area within the past 12 months
• 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.
• Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study
• History of non-compliance with clinical research protocols
• Ablative laser resurfacing to on their face within 12 months
• Non-ablative laser or light procedures to their face within the past 3 months
• Known allergy to Restylane® Silk or any of its constituents

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead

Study Sites (1)

Cosmetic Laser Dermatology

San Diego, California, 92121, United States

RECRUITING

Study Officials

• Mitchel P Goldman, MD

  Cosmetic Laser Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabella Guiha, CCRC

CONTACT

858 657 1004; IGuiha@CLDerm.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 9, 2018
• Study Start: February 26, 2019
• Primary Completion: April 1, 2020
• Study Completion: August 1, 2020
• Last Updated: May 3, 2019

Record last verified: 2019-05

Locations

US (1)