Correction of the Moderate to Severe Nasolabial FoldsNCT03282357

Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Nasolabial Folds in China

A study testing Radiesse injectable implant (dermal filler) and Restylane injectable implant (dermal filler) in people with Correction of the Moderate to Severe Nasolabial Folds, run by Merz North America, Inc. at 4 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

The objectives of this study are to evaluate the effectiveness and safety of Radiesse for the correction of nasolabial folds (NLFs). Read more about this study

Who is it for?: Ages 22 to 65 years
Conditions the study is for: Correction of the Moderate to Severe Nasolabial Folds
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: 181 participants
Where: 4 sitesChina
Study dates: 27 Jul 2017to 30 Nov 2018
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

Is 22 - 65 years of age.
Has symmetrical NLFs of moderate or severe intensity (grade 3 or 4) on the WSRS as determined by the independent blinded evaluator and confirmed by the treating investigator at baseline.
Both folds must have the same NLF score at baseline. 4. Has signed an informed consent.
5. Understands and accepts the obligation not to receive any other facial procedures below the eyes during the study.
6. Understands and accepts the obligation to present for all scheduled follow-up visits and is logistically able to meet all study requirements.
7. Subjects of childbearing potential must have a negative pregnancy test result and must not be lactating at the Screening/Baseline Visit and be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will be considered if one of the following conditions is documented on the medical history:
Postmenopausal with last menstrual bleeding at least 12 months prior to study; and
Without a uterus and/or both ovaries.

Who cannot join

Has received surgical permanent implants, grafting, or surgery below the eyes on the face prior to injection or lower lid blepharoplasty within 6 months prior to injection.
Has received within the specified (washout) period or plans to receive treatment during the study conduct with a non-permanent facial filler in any facial area below the eyes:
12 months prior to study start - hyaluronic acid [HA] or collagen
18 months prior to study start - calcium hydroxylapatite [CaHA]
Has received at any time or plans to receive during the study a permanent facial filler (e.g. poly L-lactic acid [PLLA], polymethyl-methacrylate [PMMA], silicone) below the eyes.
Has received within the past 6 months or plans to receive during the study facial dermal resurfacing procedures (e.g. chemical peel, dermabrasion, ablative laser resurfacing), non-invasive skin-tightening (e.g. Thermage), botulinum toxin injections, mesotherapy, or fat injections below the eyes.

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Has received in the past 2 weeks or plans to receive during the study any prescription wrinkle therapies (e.g. RENOVAÒ), topical steroids, skin irritating topical preparations, or pigmenting agents (self-tanning agents) for use on the face.
Has received in the past 2 months, or plans to receive immunosuppressive medications or systemic steroids (intranasal/inhaled steroids acceptable) during the study.
Has an acute inflammatory process or infection, active herpes infection, or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of adverse events (AEs).
Has a known bleeding disorder or has received or is planning to receive anti-coagulation, anti-platelet, or thrombolytic medications (e.g., warfarin), anti-inflammatory drugs (oral/injectable corticosteroids or NSAIDs (e.g., aspirin, ibuprofen), or other substances known to increase coagulation time (vitamins or herbal supplements, e.g., Vitamin E, garlic, gingko), from 10 days before injection to 3 days after injection.
Has a history of known liver or renal function disease/disorder or has clinically significant laboratory values at baseline.
Has a known history of allergic/anaphylactic reactions, including hypersensitivity to lidocaine or anesthetics of the amide type, or any of the device components.
Has a history of hyper- or hypo-pigmentation in the NLFs, keloid formation, or hypertrophic scarring.
Has recently lost or has the intention to lose a significant amount of weight ≥ 2 Body Mass Index (BMI) units during the course of the study.
Has any other medical condition with the potential to interfere with the study's conduct or assessments, or increase the risk of AEs.
Has participated in a study in the last 30 days or is enrolled or plans to enroll in any other interfering investigational study during participation in the study.
Is an employee or direct relative of an employee of the investigational department in site or the sponsor.

Trial locations and contacts

4 sites in 1 country.

China4 sites

Peking University First Hospital, Merz Investigational Site #0860003
Beijing, 100034
Southern Medical University, Nanfang Hospital, Merz Investigational Site #0860006
Guangzhou, 510515
Zhejiang Provincial People's Hospital, Merz Investigational Site #0860005
Hangzhou, 310014
Xiangya Hospital Central South University, Department of Aesthetic Plastic Surgery, Merz Investigational Site #'0860007
Hunan, 410008

Other trials in China

About this study

Official title: Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Nasolabial Folds

The objectives of this study are to evaluate the effectiveness and safety of Radiesse for the correction of nasolabial folds (NLFs).

Conditions: Correction of the Moderate to Severe Nasolabial Folds
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 suspected in an aqueous based gel carrier.
Subdermal injection.
Restylane injectable implant (dermal filler)Device
Also called Hyaluronic acid
Subdermal injection

Study groups in NCT03282357
Study group	Role	What they receive
Radiesse	Experimental	Subjects are randomized as to which of the two nasolabial folds is treated with Radiesse. Receives: Device: Radiesse injectable implant (dermal filler); Device: Restylane injectable implant (dermal filler)
Restylane	Active comparator	Subjects are randomized as to which of the two nasolabial folds is treated with Restylane. 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.

Percentage of NLFs With Treatment Success at Month 6
Treatment success was defined as a greater than or equal to (>=) 1-point improvement from baseline, as assessed by a blinded evaluator wrinkle severity rating scale (WSRS) scale. WSRS is a 5 point scale with scores as Score 1: Absent; Score 2: Mild; Score 3: Moderate; Score 4: Severe; Score 5: Extreme.
Measured: Month 6

Secondary outcomes (1)

Percentage of NLFs With an Improvement in the Blinded Evaluator's GAIS Score at Month 6
The blinded evaluator rated the current cosmetic result for each NLF according to the GAIS based on live assessments during the visit compared with photographs taken at baseline before administration of treatment on each NLF. An improvement on the GAIS was classified as "improved", "much improved", or "very much improved. The GAIS is a 7-point scale, where: +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), and -3 (very much worse).
Measured: Month 6

Timeline

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

27 Jul 201730 Nov 2018

First posted13 Sep 2017
Study start27 Jul 2017
Primary completion17 Jul 2018
Study completion30 Nov 2018

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 the Moderate to Severe 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: Randomised
Intervention model: Single group
Model description: Split-face
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 181 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03282357
Sponsor's protocol ID: M900311004
Status last verified: Nov 2020
First submitted: 12 Sep 2017
Last updated: 23 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
A Study to Confirm Safety and Effectiveness of RADIESSE® Injectable Implant for the Correction of Moderate to Severe Nasolabial Folds
Nasolabial Folds
Active, not recruitingObservational study
Filler Post Market Survey (FIPS)
Wrinkle Reduction
Active, not recruiting
Study of JTM104 Injection vs. Juvederm in Treating Moderate to Severe Nasolabial Folds
Nasolabial Folds, Wrinkles
Not yet recruiting
Study of DIOSHA S Lido Injection vs. YOUTHFILL Fine With Lidocaine in Treating Moderate to Severe Nasolabial Folds
Nasolabial Folds, Wrinkles
Active, not recruiting
To Evaluate the Efficacy and Safety of 'BRDE33-100' for the Temporary Correction of Moderate to Severe Nasolabial Folds
Nasolabial Folds

All Correction of the Moderate to Severe Nasolabial Folds trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2021. 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 Nasolabial Folds
ClinicalTrials.gov ID: NCT03282357
Acronym / sponsor ID: M900311004
Conditions: Correction of the Moderate to Severe Nasolabial Folds
Study type: Interventional
Recruitment status: Completed
Enrolment: 181 participants (actual)
Lead sponsor: Merz North America, Inc.Industry (pharma, biotech, devices)
Study start: 27 Jul 2017 (actual)
Primary completion: 17 Jul 2018 (actual)
Study completion: 30 Nov 2018 (actual)
First posted: 13 Sep 2017 (actual)
Results: Posted 23 Feb 2021

Clinical summary

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

The objectives of this study are to evaluate the effectiveness and safety of Radiesse for the correction of nasolabial folds (NLFs).

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
Radiesse	Experimental	Device: Radiesse injectable implant (dermal filler), Device: Restylane injectable implant (dermal filler)Subjects are randomized as to which of the two nasolabial folds is treated with Radiesse.
Restylane	Active comparator	Device: Radiesse injectable implant (dermal filler), Device: Restylane injectable implant (dermal filler)Subjects are randomized as to which of the two nasolabial folds is treated with Restylane.

Who may qualify

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

Key inclusion criteria (8 listed)

Is 22 - 65 years of age.
Has symmetrical NLFs of moderate or severe intensity (grade 3 or 4) on the WSRS as determined by the independent blinded evaluator and confirmed by the treating investigator at baseline.
Both folds must have the same NLF score at baseline. 4. Has signed an informed consent.
5. Understands and accepts the obligation not to receive any other facial procedures below the eyes during the study.
6. Understands and accepts the obligation to present for all scheduled follow-up visits and is logistically able to meet all study requirements.

Key exclusion criteria (17 listed)

Has received surgical permanent implants, grafting, or surgery below the eyes on the face prior to injection or lower lid blepharoplasty within 6 months prior to injection.
Has received within the specified (washout) period or plans to receive treatment during the study conduct with a non-permanent facial filler in any facial area below the eyes:
Has received at any time or plans to receive during the study a permanent facial filler (e.g. poly L-lactic acid [PLLA], polymethyl-methacrylate [PMMA], silicone) below the eyes.
Has received within the past 6 months or plans to receive during the study facial dermal resurfacing procedures (e.g. chemical peel, dermabrasion, ablative laser resurfacing), non-invasive skin-tightening (e.g. Thermage), botulinum toxin injections, mesotherapy, or fat injections below the eyes.
Has received in the past 2 weeks or plans to receive during the study any prescription wrinkle therapies (e.g. RENOVAÒ), topical steroids, skin irritating topical preparations, or pigmenting agents (self-tanning agents) for use on the face.

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 suspected in an aqueous based gel carrier.Subdermal injection.	Device	Radiesse, Restylane
Restylane injectable implant (dermal filler)Also: Hyaluronic acidSubdermal injection	Device	Radiesse, Restylane

Primary outcome

Percentage of NLFs With Treatment Success at Month 6
Time frame: Month 6
Treatment success was defined as a greater than or equal to (>=) 1-point improvement from baseline, as assessed by a blinded evaluator wrinkle severity rating scale (WSRS) scale. WSRS is a 5 point scale with scores as Score 1: Absent; Score 2: Mild; Score 3: Moderate; Score 4: Severe; Score 5: Extreme.

1 secondary outcome

Percentage of NLFs With an Improvement in the Blinded Evaluator's GAIS Score at Month 6
Time frame: Month 6

Results and safety

Results posted to the registry on 23 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Radiesse and Restylane	181	164

Primary outcome: Percentage of NLFs With Treatment Success at Month 6

Time frame: Month 6. Number. Unit: Percentage of successfully treated NFLs

Measure	Radiesse n = 171	Restylane n = 171
Value	66.0	72.8

Radiesse vs Restylane: Difference in Percentage: -6.8 (95% CI -13.1 to -0.5)

Population analysed: The per protocol set (PPS) was the subset of the full analysis set (FAS) without any major protocol deviations. The FAS was all participants randomized who received an investigational product with at least one post-baseline effectiveness assessment (WSRS, blind evaluator's Global Aesthetic Improvement Scale \[GAIS\] or participant's GAIS assessment).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline up to Month 12. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Radiesse and Restylane	4 of 176 (2.3%)	56 of 176 (31.8%)	0 of 176

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Correction of the Moderate to Severe Nasolabial Folds

Recruiting
A Study to Confirm Safety and Effectiveness of RADIESSE® Injectable Implant for the Correction of Moderate to Severe Nasolabial Folds
Nasolabial Folds
Active, not recruitingObservational study
Filler Post Market Survey (FIPS)
Wrinkle Reduction
Active, not recruiting
Study of JTM104 Injection vs. Juvederm in Treating Moderate to Severe Nasolabial Folds
Nasolabial Folds, Wrinkles
Not yet recruiting
Study of DIOSHA S Lido Injection vs. YOUTHFILL Fine With Lidocaine in Treating Moderate to Severe Nasolabial Folds
Nasolabial Folds, Wrinkles
Active, not recruiting
To Evaluate the Efficacy and Safety of 'BRDE33-100' for the Temporary Correction of Moderate to Severe Nasolabial Folds
Nasolabial Folds

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.

4 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 8 inclusion and 17 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 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 Feb 2021). 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?

Percentage of NLFs With Treatment Success at Month 6 (time frame: Month 6). 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 NCT03282357.

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 Feb 2021.