Correction of Moderate to Severe Nasolabial Folds (NLFs)NCT04647721

Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Moderate to Severe Nasolabial Folds

A study testing Radiesse injectable implant (dermal filler) and Restylane injectable implant (dermal filler) in people with Correction of Moderate to Severe Nasolabial Folds (NLFs), run by Merz North America, Inc. at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Effectiveness: The purpose of this study is to demonstrate the non-inferiority of Radiesse (CaHA) to Restylane (HA) following subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as NLFs. Safety: To evaluate the incidence and type of adverse events and serious adverse events. Read more about this study

Who is it for?: Ages 22 to 65 years
Conditions the study is for: Correction of Moderate to Severe Nasolabial Folds (NLFs)
What is being tested?: Radiesse injectable implant (dermal filler) and Restylane injectable implant (dermal filler)
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 134 participants
Where: 7 sitesChina
Study dates: 13 Jan 2021to 27 Apr 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 22 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has symmetrical NLFs, with the same WSRS score of 3 or 4 (moderate or severe) for both right and left NLFs, as determined on live assessment by the blinded evaluator.
Is ≥ 22 and ≤ 65 years of age.
Is willing to abstain from all other aesthetic treatments on any part of the face, including but not limited to injectable fillers, implants, neurotoxin, skin peels, laser treatments, surgical treatments, etc. for the trial's duration.

Who cannot join

Has an acute inflammatory process or active infection at the injection site.
Has received mid- and/or lower-facial region treatments with any dermal fillers.
Has received facial dermal therapies.
Had prior surgery in the mid- and/or lower-facial area, including the NLFs, or has a permanent implant or graft in the mid- and/or lowerfacial area that could interfere with effectiveness assessments.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

China7 sites

Peking University First Hospital, Merz Investigational Site #0860003
Beijing, 100034
Peking University Third Hospital, Merz Investigational Site #0860009
Beijing
The Third Affiliated Hospital, Sun Yat-Sen University, Merz Investigational Site #0860023
Guangzhou, 510000
Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Merz Investigational Site #0860030
Hangzhou, 310006
Zhejiang Provincial People's Hospital, Merz Investigational Site #0860005
Hangzhou, 310014
Zhongda Hospital Southeast University, Merz Investigational Site #0860022
Nanjing
RenMin Hospital of Wuhan University, Merz Investigational Site #0860014
Wuhan, 430060

Other trials in China

About this study

Safety: To evaluate the incidence and type of adverse events and serious adverse events.

Conditions: Correction of Moderate to Severe Nasolabial Folds (NLFs)
Being tested: Radiesse injectable implant (dermal filler), Restylane injectable implant (dermal filler)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Radiesse injectable implant (dermal filler)Device
Also called Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
Subdermal injection.
Restylane injectable implant (dermal filler)Device
Also called Hyaluronic acid
Subdermal injection.

Study groups in NCT04647721
Study group	Role	What they receive
Left side Radiesse® / Right side Restylane®	Experimental	Not described Receives: Device: Radiesse injectable implant (dermal filler); Device: Restylane injectable implant (dermal filler)
Left side Restylane® / Right side Radiesse®	Experimental	Not described Receives: Device: Radiesse injectable implant (dermal filler); Device: Restylane injectable implant (dermal filler)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to Week 24 on the Wrinkle Severity Rating Scale (WSRS)
Severity of the nasolabial folds (NLFs) was assessed and measured using the 5-point Wrinkle Severity Rating Scale (WSRS), where 1=absent and 5=extreme. A lower score indicates better outcome.
Measured: Baseline and Week 24 after last injection, up to 28 weeks

Secondary outcomes (3)

Proportion of Subjects With Improvement on the Investigator Global Aesthetic Improvement Scale (iGAIS) for Each Nasolabial Fold (NLF) at Week 24
The Investigator Global Aesthetic Improvement Scale is a subjective assessment where the treating physician describes the degree of improvement in facial appearance ranging from "Very much improved" (+3) to "Very much worse" (-3). The investigator was asked to rate each NLF separately and select the rating that best applied when asked "What is the overall impression of aesthetic change of the subject's NLF due to treatment, compared to the pretreatment photograph". Improvement was defined as a rating of +1, +2, or +3. The higher the iGAIS score, the greater the improvement. Proportion refers to percentage of participants.
Measured: Week 24 after last injection, up to 28 weeks
Proportion of Subjects With Any Improvement on the Subject Global Aesthetic Improvement Scale (sGAIS) for Each Nasolabial Fold (NLF) at Week 24
The Subject Global Aesthetic Improvement Scale is a subjective self-assessment where the subject independently describes the degree of improvement in facial appearance ranging from "Very much improved" (+3) to "Very much worse" (-3). Subjects rated each NLF separately when asked "What is the overall impression of aesthetic change of your NLF due to treatment, compared to the pretreatment photograph?" Improvement is defined as a rating of +1, +2, or +3. The higher the sGAIS score, the greater the improvement. Proportion refers to percentage of participants.
Measured: Week 24 after last injection, up to 28 weeks
Number of Subjects With Treatment-emergent Adverse Events (AE) Related to Radiesse
Defined as AEs with onset at or after date of first administration of Radiesse. An AE was considered to be "related" if a causal relationship between Radiesse or the treatment procedure and the AE is at least reasonably possible.
Measured: Baseline to week 48 after last injection, up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jan 202127 Apr 2022

First posted1 Dec 2020
Study start13 Jan 2021
Primary completion8 Nov 2021
Study completion27 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Correction of Moderate to Severe Nasolabial Folds (NLFs)Studies 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: Randomised
Intervention model: Single group
Model description: Split-face
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 134 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04647721
Sponsor's protocol ID: M900311009
Status last verified: Jan 2023
First submitted: 23 Nov 2020
Last updated: 23 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Moderate to Severe Nasolabial Folds
ClinicalTrials.gov ID: NCT04647721
Acronym / sponsor ID: M900311009
Conditions: Correction of Moderate to Severe Nasolabial Folds (NLFs)
Study type: Interventional
Recruitment status: Completed
Enrolment: 134 participants (actual)
Lead sponsor: Merz North America, Inc.Industry (pharma, biotech, devices)
Study start: 13 Jan 2021 (actual)
Primary completion: 8 Nov 2021 (actual)
Study completion: 27 Apr 2022 (actual)
First posted: 1 Dec 2020 (actual)
Results: Posted 23 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Safety: To evaluate the incidence and type of adverse events and serious adverse events.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Split-face

Arm	Type	Receives
Left side Radiesse® / Right side Restylane®	Experimental	Device: Radiesse injectable implant (dermal filler), Device: Restylane injectable implant (dermal filler)
Left side Restylane® / Right side Radiesse®	Experimental	Device: Radiesse injectable implant (dermal filler), Device: Restylane injectable implant (dermal filler)

Who may qualify

Ages: 22 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Has symmetrical NLFs, with the same WSRS score of 3 or 4 (moderate or severe) for both right and left NLFs, as determined on live assessment by the blinded evaluator.
Is ≥ 22 and ≤ 65 years of age.
Is willing to abstain from all other aesthetic treatments on any part of the face, including but not limited to injectable fillers, implants, neurotoxin, skin peels, laser treatments, surgical treatments, etc. for the trial's duration.

Key exclusion criteria (4 listed)

Has an acute inflammatory process or active infection at the injection site.
Has received mid- and/or lower-facial region treatments with any dermal fillers.
Has received facial dermal therapies.
Had prior surgery in the mid- and/or lower-facial area, including the NLFs, or has a permanent implant or graft in the mid- and/or lowerfacial area that could interfere with effectiveness assessments.

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
Radiesse injectable implant (dermal filler)Also: Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.Subdermal injection.	Device	Left side Radiesse® / Right side Restylane®, Left side Restylane® / Right side Radiesse®
Restylane injectable implant (dermal filler)Also: Hyaluronic acidSubdermal injection.	Device	Left side Radiesse® / Right side Restylane®, Left side Restylane® / Right side Radiesse®

Primary outcome

Change From Baseline to Week 24 on the Wrinkle Severity Rating Scale (WSRS)
Time frame: Baseline and Week 24 after last injection, up to 28 weeks
Severity of the nasolabial folds (NLFs) was assessed and measured using the 5-point Wrinkle Severity Rating Scale (WSRS), where 1=absent and 5=extreme. A lower score indicates better outcome.

3 secondary outcomes

Proportion of Subjects With Improvement on the Investigator Global Aesthetic Improvement Scale (iGAIS) for Each Nasolabial Fold (NLF) at Week 24
Time frame: Week 24 after last injection, up to 28 weeks
Proportion of Subjects With Any Improvement on the Subject Global Aesthetic Improvement Scale (sGAIS) for Each Nasolabial Fold (NLF) at Week 24
Time frame: Week 24 after last injection, up to 28 weeks
Number of Subjects With Treatment-emergent Adverse Events (AE) Related to Radiesse
Time frame: Baseline to week 48 after last injection, up to 52 weeks

Results and safety

Results posted to the registry on 23 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Left Side Radiesse® / Right Side Restylane®	61	59
Left Side Restylane® / Right Side Radiesse®	60	58

Primary outcome: Change From Baseline to Week 24 on the Wrinkle Severity Rating Scale (WSRS)

Time frame: Baseline and Week 24 after last injection, up to 28 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Restylane n = 115	Radiesse n = 115
Baseline	3.4 (0.50)	3.4 (0.50)
Week 24	2.4 (0.62)	2.4 (0.70)

Restylane vs Radiesse: Difference in Least Squares Means: 0.03 (95% CI -0.07 to 0.12)

Population analysed: This analysis population includes all randomized and treated subjects with no major protocol deviations or other events that impact analysis of the primary effectiveness endpoint (Per Protocol Set) with observed cases at the Week 24 visit.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Restylane	0 of 120 (0%)	7 of 120 (5.8%)	0 of 120
Radiesse	0 of 120 (0%)	18 of 120 (15%)	0 of 120
Non-NLF	7 of 120 (5.8%)	9 of 120 (7.5%)	0 of 120

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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.

Merz Medical Expert study director

Merz North America, Inc.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 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 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. 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?

Yes. Results are posted in the registry (first posted 23 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline to Week 24 on the Wrinkle Severity Rating Scale (WSRS) (time frame: Baseline and Week 24 after last injection, up to 28 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 NCT04647721.

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 23 Jan 2023.