Hyaluronic Filler for Improvement of Radial Cheek Lines

NCT06074302 | Completed FDA Device

• 1 other identifier: RHA10823
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Appearance of superficial radial cheek lines and fine lines of the cheek are signs of photoaging. These lines appear in a curvilinear or crosshatched fashion on the lower cheeks in photoaged individuals. They represent a common concern among patients seeking cosmetic treatments. With the aging population and increasing social awareness of cosmetic treatments, it is likely that the demand for filler procedures will increase. Current treatment options for these lines include fractionated and fully ablative laser resurfacing, topical retinoids, intradermal filler injections, and chemical peels. One potential treatment for facial fine lines include use of low G' hyaluronic acid fillers, which allow for dynamic movement while also addressing the appearance of the lines. Resilient Hyaluronic Acid (RHA) Redensity is an FDA-cleared filler used for treatment of dynamic perioral rhytids. Hyaluronic acid-based fillers have been shown to improve overall skin texture (skin surface hydration, roughness, and elasticity) through the hypothesized mechanism of inducing a fibroblast response to boost collagen production. They have the potential to reduce appearance of facial fine lines of the cheek. This study will evaluate the efficacy of RHA Redensity in improving radial cheek lines.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• Allergan Fine Lines Scale

  1-point improvement of facial fine lines of the cheek based on the validated Allergan Fine Lines Scale between baseline and 8-week follow-up. Scale is a 5-point scale rated from 0 to 4, with 0 representing no fine lines and 4 representing diffuse fine lines with cross-hatching.

  10 weeks

Secondary Outcomes (1)

• FACE-Q Appraisal of Lines: Overall

  10 weeks

Study Arms (1)

Treatment of radial cheek lines with RHA Redensity

EXPERIMENTAL

A total of 20 patients with facial fine lines of the cheeks/radial cheek lines will be treated with RHA Redensity. They will receive 2 treatments. During the first treatment visit, up to 2cc of RHA Redensity will be injected in a microdroplet technique per cheek. The boundaries of the injection area will be defined by the nasolabial fold, nasojugal groove, palpebromalar groove, mandible, and preauricular crease. Patients will return in 4 weeks for another treatment visit using the same technique. At 8 weeks, they will return for a follow-up visit.

Device: RHA Redensity

Interventions

RHA Redensity DEVICE

RHA Redensity will be injected in a microdroplet technique to bilateral cheeks.

Treatment of radial cheek lines with RHA Redensity

Eligibility Criteria

• Age: 31 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or great
• Rating of 2, 3, or 4 on 5-point Allergan Fine Lines Scale on the cheeks

You may not qualify if:

• Pregnancy
• Prior adverse reaction to hyaluronic acid treatment (injectable or over-the-counter topical)
• Connective tissue disorder
• Active infection in treatment area
• Active severe inflammatory disease in treatment area such as atopic dermatitis, psoriasis
• Treatment with toxin or filler in lower face below the orbital rim within the past 6 months

Sponsors & Collaborators

• Main Line Center for Laser Surgery: lead

Study Sites (1)

Main Line Center for Laser Surgery

Ardmore, Pennsylvania, 19003, United States

Location

Related Publications (1)

• Alzahrani F, Alajmi A, Lee KC. A Dynamic, High-Stretch Resilient Hyaluronic Acid Filler Improves Fine Lines of the Cheek and Patient-Reported Outcomes. Dermatol Surg. 2025 Mar 26;51(8):773-777. doi: 10.1097/DSS.0000000000004625.

  PMID: 40135789 DERIVED

Study Officials

• Kachiu Lee

  Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: October 10, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)