UnknownNot Applicable

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

United States20 participantsStarted 2019-02-26

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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;
✓. Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device

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

What they're measuring

Efficacy

Timeframe: Baseline to Day 180 post treatment

Trial details

NCT IDNCT03461198

SponsorGoldman, Butterwick, Fitzpatrick and Groff

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-01

Contact for this trial

Isabella Guiha, CCRC

858 657 1004 IGuiha@CLDerm.com

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