Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06074302 |
Other study ID # |
RHA10823 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 1, 2023 |
Est. completion date |
November 1, 2025 |
Study information
Verified date |
October 2023 |
Source |
Main Line Center for Laser Surgery |
Contact |
Jessica Plugis |
Phone |
610-645-5551 |
Email |
jess[@]dermguy.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.