Nasolabial FoldsRadiesse ChinaNCT07856797
A Study to Confirm Safety and Effectiveness of RADIESSE® Injectable Implant for the Correction of Moderate to Severe Nasolabial Folds
A study testing Subdermal Implant in people with Nasolabial Folds, run by Merz North America, Inc..
Trial summary
The purpose of this study is to confirm the long-term safety, effectiveness, and degradation profile of RADIESSE® Injectable Implant for the correction of moderate to severe nasolabial folds (NLFs) in Chinese adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- Subdermal Implant
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- WSRS score of 3 (moderate) or 4 (severe) in both right and left NLFs, as determined live by the treating investigator. The WSRS score for the right and the left NLF does not have to be equal.
- Willing to abstain from other aesthetic treatments in the NLF area during study participation.
Who cannot join
- Prior dermal filler or implant material detectable in the NLF area by ultrasound.
- Active infection or acute inflammation at treatment sites.
- Hyaluronic Acid or collagen filler treatment in NLFs within 12 months.
- CaHA or Poly L-Lactic Acid filler treatment in NLFs within 24 months.
- Recent facial dermal therapies in the midface region within the past 6 months.
- Prior facial surgery or implants that could interfere with assessments.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Open-Label, Multicenter, Post-Market Clinical Follow-Up Study to Confirm the Long-term Safety and Effectiveness of RADIESSE® Injectable Implant for the Correction of Moderate to Severe Nasolabial Folds
The purpose of this study is to confirm the long-term safety, effectiveness, and degradation profile of RADIESSE® Injectable Implant for the correction of moderate to severe nasolabial folds (NLFs) in Chinese adults. Eligible participants will receive treatment with RADIESSE® Injectable Implant in both NLFs and may receive an optional touch-up treatment at Month 1 at investigator's discretion. Participants will be followed for up to 24 months after last treatment.
- Conditions
- Nasolabial Folds
- Being tested
- Subdermal Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subdermal ImplantDevice
Also called Calcium Hydroxylapatite (CaHA)
Participants will receive treatment with RADIESSE® Injectable Implant.
| Study group | Role | What they receive |
|---|---|---|
| RADIESSE® Injectable Implant | Experimental | Participants will receive a single injection of RADIESSE® administered to both NLFs on Day 1. Participants may receive an optional touch-up injection at Month 1 following the initial treatment at investigator's discretion. RADIESSE® will be administered according to the current product labelling and instruction for use. Receives: Device: Subdermal Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving at Least a 1-point Improvement in Both NLFs From Baseline to Month 6 after Last Treatment on the Wrinkle Severity Rating Scale (WSRS), as Assessed Live by the Treating Investigator
Severity of the NLFs was assessed and measured using the 5-point WSRS, where 1=absent and 5=extreme. A lower score indicates better outcome.
Measured: At Month 6 after last treatment
Secondary outcomes (2)
Percentage of Participants Achieving Improvement (Score of 1, 2, 3) on the Investigator Global Aesthetic Improvement Scale (iGAIS) at Month 6 After Last Treatment, as Assessed Live by the Treating Investigator
The iGAIS is an assessment grading scale where the treating investigator describes the degree of improvement in facial appearance according to the GAIS, a 5-point scale ranging from 'Very Much Improved' (1) to 'Worse' (5). The investigator will be asked to rate the NLFs and select the rating that best applies when asked "What is the overall impression of aesthetic change of the participants NLFs due to treatment, compared to the pretreatment photograph". Improvement is defined as a rating of +1, +2, or +3. The higher the iGAIS score, the greater the improvement.
Measured: At Month 6 after last treatment
Percentage of Participants Achieving Improvement (Score of 1, 2, 3) on the Participant Global Aesthetic Improvement Scale (pGAIS) at Month 6 After Last Treatment, as Assessed Live by Participant
The pGAIS is a self-assessment grading scale where the participant independently describes the degree of improvement in facial appearance according to the GAIS, a 5-point scale ranging from 'Very Much Improved' (1) to 'Worse' (5). Participants will be asked to rate the NLFs and select the rating that best applies when asked "What is the overall impression of aesthetic change of your NLFs due to treatment, compared to the pretreatment photograph?" Improvement is defined as a rating of +1, +2, or +3. The higher the pGAIS score, the greater the improvement.
Measured: At Month 6 after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasolabial FoldsStudies 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
- 163 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856797
- Sponsor's protocol ID
- RAD-NLF-CN003
- Acronym
- Radiesse China
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Multicenter, Post-Market Clinical Follow-Up Study to Confirm the Long-term Safety and Effectiveness of RADIESSE® Injectable Implant for the Correction of Moderate to Severe Nasolabial Folds
- ClinicalTrials.gov ID
- NCT07856797
- Acronym / sponsor ID
- Radiesse China / RAD-NLF-CN003
- Conditions
- Nasolabial Folds
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 163 participants (estimated)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 5 Oct 2026 (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 purpose of this study is to confirm the long-term safety, effectiveness, and degradation profile of RADIESSE® Injectable Implant for the correction of moderate to severe nasolabial folds (NLFs) in Chinese adults. Eligible participants will receive treatment with RADIESSE® Injectable Implant in both NLFs and may receive an optional touch-up treatment at Month 1 at investigator's discretion. Participants will be followed for up to 24 months after last treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RADIESSE® Injectable Implant | Experimental | Device: Subdermal ImplantParticipants will receive a single injection of RADIESSE® administered to both NLFs on Day 1. Participants may receive an optional touch-up injection at Month 1 following the initial treatment at investigator's discretion. RADIESSE® will be administered according to the current product labelling and instruction for use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- WSRS score of 3 (moderate) or 4 (severe) in both right and left NLFs, as determined live by the treating investigator. The WSRS score for the right and the left NLF does not have to be equal.
- Willing to abstain from other aesthetic treatments in the NLF area during study participation.
Key exclusion criteria (6 listed)
- Prior dermal filler or implant material detectable in the NLF area by ultrasound.
- Active infection or acute inflammation at treatment sites.
- Hyaluronic Acid or collagen filler treatment in NLFs within 12 months.
- CaHA or Poly L-Lactic Acid filler treatment in NLFs within 24 months.
- Recent facial dermal therapies in the midface region within the past 6 months.
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 |
|---|---|---|
| Subdermal ImplantAlso: Calcium Hydroxylapatite (CaHA)Participants will receive treatment with RADIESSE® Injectable Implant. | Device | RADIESSE® Injectable Implant |
Primary outcome
Percentage of Participants Achieving at Least a 1-point Improvement in Both NLFs From Baseline to Month 6 after Last Treatment on the Wrinkle Severity Rating Scale (WSRS), as Assessed Live by the Treating Investigator
Time frame: At Month 6 after last treatment
Severity of the NLFs was assessed and measured using the 5-point WSRS, where 1=absent and 5=extreme. A lower score indicates better outcome.
2 secondary outcomes
Percentage of Participants Achieving Improvement (Score of 1, 2, 3) on the Investigator Global Aesthetic Improvement Scale (iGAIS) at Month 6 After Last Treatment, as Assessed Live by the Treating Investigator
Time frame: At Month 6 after last treatment
Percentage of Participants Achieving Improvement (Score of 1, 2, 3) on the Participant Global Aesthetic Improvement Scale (pGAIS) at Month 6 After Last Treatment, as Assessed Live by Participant
Time frame: At Month 6 after last treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- 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.
Merz Medical Expert study director
Merz North America, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing Subdermal Implant in people with Nasolabial Folds, run by Merz North America, Inc..
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: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Public Disclosure Manager (+1 984-301-3095, Aesthetic.Trials@merz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving at Least a 1-point Improvement in Both NLFs From Baseline to Month 6 after Last Treatment on the Wrinkle Severity Rating Scale (WSRS), as Assessed Live by the Treating Investigator (time frame: At Month 6 after last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2026.