Aging ProblemsNCT06574750
Effect of a New HA Filler in Correcting Nasolabial Fold
A study testing CUREAⓇ (ARIBIO, Ltd., Seoul, Republic of Korea) and JuvedermⓇ (Q-Med AB, Uppsala, Sweden) in people with Aging Problems, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The investigators aimed to evaluate the efficacy and safety of new HA filler for nasolabial fold correction Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging Problems
- What is being tested?
- CUREAⓇ (ARIBIO, Ltd., Seoul, Republic of Korea) and JuvedermⓇ (Q-Med AB, Uppsala, Sweden)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Oct 2021to 8 May 2023
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who had prominent NLFs with a WSRS score of 3 or 4 on both sides
Who cannot join
- patients with active facial skin diseases or history of severe allergies, autoimmune disorders, or hypersensitivity to HA or any of the excipients contained in the investigational filler
- participants who had used a local topical preparation (steroid and retinoid) within 2 weeks before the study
- participants who had undergone chemical peeling, laser procedures, or acne treatments within 4 months before the study
- participants who had been injected with other biomaterials, including HA within 6 months before the study.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, 13620
About this study
Official title: New HA Filler Versus Juvederm for Nasolabial Fold Correction
The investigators aimed to evaluate the efficacy and safety of new HA filler for nasolabial fold correction
Read the detailed description
A 24-week prospective, single-center, assessor-blinded, randomized, split-face study was conducted to compare the clinical efficacy and safety of new HA filler versus Juvederm for nasolabial fold correction
- Conditions
- Aging Problems
- Being tested
- CUREAⓇ (ARIBIO, Ltd., Seoul, Republic of Korea), JuvedermⓇ (Q-Med AB, Uppsala, Sweden)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUREAⓇ (ARIBIO, Ltd., Seoul, Republic of Korea)Drug
Also called experimental group
Hyaluronic acid filler injection were administered into the mid-dermis of the nasolabial fold.
JuvedermⓇ (Q-Med AB, Uppsala, Sweden)Drug
Also called active control group
Hyaluronic acid filler injection were administered into the mid-dermis of the nasolabial fold.
| Study group | Role | What they receive |
|---|---|---|
| New HA filler (Curea) | Experimental | The left/right assignment was sealed in a nontransparent envelop. Receives: Drug: CUREAⓇ (ARIBIO, Ltd., Seoul, Republic of Korea) |
| Juvederm | Active comparator | The left/right assignment was sealed in a nontransparent envelop. Receives: Drug: JuvedermⓇ (Q-Med AB, Uppsala, Sweden) |
What is being measured
The primary outcome is the main question the study is designed to answer.
WSRS
Wrinkle Severity Rating Scale from 1 (no visible fold) to 5 (extremely deep and long folds)
Measured: at 24 weeks after treatment
Secondary outcomes (2)
GAIS
Global Aesthetic Improvement Scale from 3 (very much improved) to -1 (worse).
Measured: at 24 weeks after treatment
Adverse events related to the procedure
Patients were required to report any adverse events up to 24 weeks
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start16 Oct 2021
- Primary completion8 May 2023
- Study completion8 May 2023
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 Aging ProblemsStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Ri Kim, Seoul National University Bundang Hospital
- Investigators
- Bo Ri Kim, M.D., Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574750
- Sponsor's protocol ID
- E-2105/684-001
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim BR, Shin JW, Kim DW, Choung JJ, Jang Y, Lee SH, Seo BS, Huh CH. Efficacy and Safety of New Hyaluronic Acid Filler for Nasolabial Fold Correction: A Double-Blind, Randomized Trial. Plast Reconstr Surg. 2026 Feb 1;157(2):249-256. doi: 10.1097/PRS.0000000000012320. Epub 2025 Jul 21.
PubMed 40707029
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New HA Filler Versus Juvederm for Nasolabial Fold Correction
- ClinicalTrials.gov ID
- NCT06574750
- Acronym / sponsor ID
- E-2105/684-001
- Conditions
- Aging Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 16 Oct 2021 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 28 Aug 2024 (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.
The investigators aimed to evaluate the efficacy and safety of new HA filler for nasolabial fold correction
Detailed description
A 24-week prospective, single-center, assessor-blinded, randomized, split-face study was conducted to compare the clinical efficacy and safety of new HA filler versus Juvederm for nasolabial fold correction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New HA filler (Curea) | Experimental | Drug: CUREAⓇ (ARIBIO, Ltd., Seoul, Republic of Korea)The left/right assignment was sealed in a nontransparent envelop. |
| Juvederm | Active comparator | Drug: JuvedermⓇ (Q-Med AB, Uppsala, Sweden)The left/right assignment was sealed in a nontransparent envelop. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who had prominent NLFs with a WSRS score of 3 or 4 on both sides
Key exclusion criteria (4 listed)
- patients with active facial skin diseases or history of severe allergies, autoimmune disorders, or hypersensitivity to HA or any of the excipients contained in the investigational filler
- participants who had used a local topical preparation (steroid and retinoid) within 2 weeks before the study
- participants who had undergone chemical peeling, laser procedures, or acne treatments within 4 months before the study
- participants who had been injected with other biomaterials, including HA within 6 months before the study.
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 |
|---|---|---|
| CUREAⓇ (ARIBIO, Ltd., Seoul, Republic of Korea)Also: experimental groupHyaluronic acid filler injection were administered into the mid-dermis of the nasolabial fold. | Drug | New HA filler (Curea) |
| JuvedermⓇ (Q-Med AB, Uppsala, Sweden)Also: active control groupHyaluronic acid filler injection were administered into the mid-dermis of the nasolabial fold. | Drug | Juvederm |
Primary outcome
WSRS
Time frame: at 24 weeks after treatment
Wrinkle Severity Rating Scale from 1 (no visible fold) to 5 (extremely deep and long folds)
2 secondary outcomes
GAIS
Time frame: at 24 weeks after treatment
Adverse events related to the procedure
Time frame: up to 24 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 28 Aug 2024.
- Derived from this study: PubMed 40707029Kim BR, Shin JW, Kim DW, Choung JJ, Jang Y, Lee SH, Seo BS, Huh CH. Efficacy and Safety of New Hyaluronic Acid Filler for Nasolabial Fold Correction: A Double-Blind, Randomized Trial. Plast Reconstr Surg. 2026 Feb 1;157(2):249-256. doi: 10.1097/PRS.0000000000012320. Epub 2025 Jul 21.
- 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.
Bo Ri Kim, M.D., Ph.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CUREAⓇ (ARIBIO, Ltd., Seoul, Republic of Korea) and JuvedermⓇ (Q-Med AB, Uppsala, Sweden) in people with Aging Problems, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 1 inclusion and 4 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 28 Aug 2024. 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 South Korea. 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?
WSRS (time frame: at 24 weeks after treatment). 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 NCT06574750, 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 28 Aug 2024.