- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03461198
Micro-injections of Transparent Hyaluronic Acid Gel (Restylane® Silk) for Rejuvenation of the Aging Cheek
May 1, 2019 updated by: Goldman, Butterwick, Fitzpatrick and Groff
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
Detailed Description
This is a single center, prospective, open-label, clinical trial using micro-injections of Restylane® 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 a defined area of mid to low cheeks.
The injections will be delivered intradermally via multiple 0.02 cc microinjections distributed in a grid array pattern with 1 cm between each injection point.
A total surface area of 9-15 cm2 per cheek will be treated depending on the extent of fine lines in each subject.
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.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92121
- Recruiting
- Cosmetic Laser Dermatology
-
Contact:
- Isabella C Guiha
- Phone Number: 119 858-657-1004
- Email: IGuiha@CLDerm.com
-
Contact:
- Kristi Cobb
- Phone Number: 139 8586571004
- Email: KCobb@CLDerm.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment
Restylane® Silk to a defined area of mid to low cheeks.
|
Restylane® Silk to a defined area of mid to low cheeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy
Time Frame: Baseline to Day 180 post treatment
|
Improvement on a validated 9-point Goldman-Fitzpatrick Wrinkle Scale (GFWS)
|
Baseline to Day 180 post treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 26, 2019
Primary Completion (ANTICIPATED)
April 1, 2020
Study Completion (ANTICIPATED)
August 1, 2020
Study Registration Dates
First Submitted
March 5, 2018
First Submitted That Met QC Criteria
March 5, 2018
First Posted (ACTUAL)
March 9, 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
- Restylane Silk Microinjections
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.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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