Status:
UNKNOWN
Micro-injections of Transparent Hyaluronic Acid Gel (Restylane® Silk) for Rejuvenation of the Aging Cheek
Lead Sponsor:
Goldman, Butterwick, Fitzpatrick and Groff
Conditions:
Wrinkle
Eligibility:
All Genders
18+ years
Phase:
NA
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.
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 enro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03461198
Start Date
February 26 2019
End Date
August 1 2020
Last Update
May 3 2019
Active Locations (1)
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1
Cosmetic Laser Dermatology
San Diego, California, United States, 92121