Clinical trial NCT06074302: Hyaluronic Filler for Improvement of Radial Cheek Lines
Official title: Use of a Hyaluronic Acid Filler (Resilient Hyaluronic Acid [RHA] Redensity) for Improvement of Radial Cheek Lines
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aging
Lead sponsor: Main Line Center for Laser Surgery
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 20
Sex: ALL
Minimum age (years): 31
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This clinical investigation is a prospective study consisting of a 2 treatment visits and a follow-up visit. A total of 20 patients will be recruited.

Treatment Plan Screening Visit and Treatment Visit 1 A total of 20 patients with facial fine lines of the cheeks/radial cheek lines will be treated with Resilient Hyaluronic Acid (RHA) Redensity, off-label. Patients will be consented, photographed with the Canfield Visia, and be asked to fill out the Facial Appearance, Health-Related Quality of Life and Adverse Effects (FACE-Q) Appraisal of Lines: Overall and FACE-Q Age Appraisal Visual Analog Scale surveys. The physician will fill out the Allergan Fine Lines Scale.

After discussion with the patient, volume of filler needed will be determined at the discretion of the provider, up to 2cc per cheek. RHA Redensity will be applied using a microdroplet technique, with approximately 0.02-0.04cc of product injected sub-dermally approximately 0.5-1cm apart on the malar and nasolabial cheek. The boundaries of the injection area will be defined by the nasolabial fold, nasojugal groove, palpebromalar groove, mandible, and preauricular crease. After treatment, the area will be lightly massaged by the physician. The patient will be asked to ice the area 3 times daily for 24 hours and post-op instructions will be provided.

Treatment Visit 2 (4 weeks +/- 2 weeks) Photographs using the Canfield Visia will be taken. Patients will return for a repeat treatment of RHA Redensity of the cheek using the microdroplet technique as described above. A maximum of 2cc will be used per cheek.

Follow-up visit (8 weeks +/-2 weeks) Patients will be photographed and will be asked to fill out the FACE-Q Appraisal of Lines: Overall and FACE-Q Age Appraisal Visual Analog Scale surveys. The physician will fill out the Allergan Fine Lines Scale. The patient will fill out the FACE-Q Appraisal of Lines: Overall and FACE-Q Age Appraisal Visual Analog Scale surveys. Photographs of the patient will be captured using the Canfield Visia camera.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Allergan Fine Lines Scale
timeFrame: 10 weeks
Secondary outcomes:
measure: FACE-Q Appraisal of Lines: Overall
timeFrame: 10 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Physician
name: Kachiu Lee
role: PRINCIPAL_INVESTIGATOR
References: