AgingNCT06074302
Hyaluronic Filler for Improvement of Radial Cheek Lines
A study testing RHA Redensity in people with Aging, run by Main Line Center for Laser Surgery at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 31 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- RHA Redensity
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 31 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 31 years old or great
- Rating of 2, 3, or 4 on 5-point Allergan Fine Lines Scale on the cheeks
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Main Line Center for Laser Surgery
Ardmore, Pennsylvania, 19003
About this study
Official title: Use of a Hyaluronic Acid Filler (Resilient Hyaluronic Acid [RHA] Redensity) for Improvement of Radial Cheek Lines
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.
Read the 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.
- Conditions
- Aging
- Being tested
- RHA Redensity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RHA RedensityDevice
RHA Redensity will be injected in a microdroplet technique to bilateral cheeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: RHA Redensity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (1)
FACE-Q Appraisal of Lines: Overall
Improvement in scores in patient-reported outcomes based on the validated FACE-Q Appraisal of Lines: Overall between baseline and 8-week follow-up. Scale is scored on a 1-100 scale, with 100 representing excellent quality of life with regards to facial fine lines.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Nov 2023
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Main Line Center for Laser Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kachiu Lee, MD, Main Line Center for Laser Surgery
- Investigators
- Kachiu Lee, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074302
- Sponsor's protocol ID
- RHA10823
- Status last verified
- Oct 2025
- First submitted
- 27 Jul 2023
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40135789
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Hyaluronic Acid Filler (Resilient Hyaluronic Acid [RHA] Redensity) for Improvement of Radial Cheek Lines
- ClinicalTrials.gov ID
- NCT06074302
- Acronym / sponsor ID
- RHA10823
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Main Line Center for Laser SurgeryUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment of radial cheek lines with RHA Redensity | Experimental | Device: RHA RedensityA 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. |
Who may qualify
- Ages
- 31 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 31 years old or great
- Rating of 2, 3, or 4 on 5-point Allergan Fine Lines Scale on the cheeks
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RHA RedensityRHA Redensity will be injected in a microdroplet technique to bilateral cheeks. | Device | Treatment of radial cheek lines with RHA Redensity |
Primary outcome
Allergan Fine Lines Scale
Time frame: 10 weeks
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.
1 secondary outcome
FACE-Q Appraisal of Lines: Overall
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Derived from this study: PubMed 40135789Alzahrani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kachiu Lee principal investigator
Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RHA Redensity in people with Aging, run by Main Line Center for Laser Surgery at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allergan Fine Lines Scale (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06074302, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.