Restylane Silk Microinjections to Cheeks

Status unconfirmed · Not applicable

Conditions studied: Wrinkle

In brief

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.

Key facts

Study ID

NCT03742479

Run by

Goldman, Butterwick, Fitzpatrick and Groff

People needed

20

Starts

2019-02-26

Expected to finish

2020-02-01

Last updated by the study team

2019-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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:
• 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:
• 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).
• f. 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
• Extremely Severe aging face with extensive photodamage
• 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

Where it is running

• West Dermatology Research Center — San Diego, California, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.