Correction of Moderate to Severe Nasolabial FoldsNCT03319719
Evaluation of Pain With Belotero® Balance With Integral Lidocaine for Correction of the Nasolabial Folds
A study testing Belotero® Balance with integral lidocaine and Belotero® Balance in people with Correction of Moderate to Severe Nasolabial Folds, run by Merz North America, Inc. at 3 sites in United States.
Trial summary
Demonstrate the effectiveness of Belotero Balance with lidocaine (Test group) for the reduction of injection-related pain in comparison to Belotero Balance without lidocaine (Control group) for the correction of NLFs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Correction of Moderate to Severe Nasolabial Folds
- What is being tested?
- Belotero® Balance with integral lidocaine and Belotero® Balance
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Sep 2017to 6 Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has right and left NLF ratings of 2 or 3 (moderate or severe) on the Merz NLF Scale, as determined by the blinded evaluator.
- Has the same Merz NLF Scale rating on both NLFs (i.e., symmetrical NLFs).
- Is at least 18 years of age.
- Understands and accepts the obligation not to receive any other procedures (i.e., dermal fillers, toxin treatments, facial ablative or fractional laser, microderm abrasion, chemical peels, non-invasive skin-tightening [e.g., Ultherapy, Thermage], or surgical procedures) below the orbital rim on the face during study participation.
Who cannot join
- Had prior surgery in the mid- and/or lower-face area, including the nasolabial fold(s), or has a permanent implant or graft in the mid- and/or lower-face area that could interfere with effectiveness assessments. (NOTE: Rhinoplasty is permitted if the procedure was ≥ 12 months prior to study enrollment.)
- Has skin or fat atrophy, beyond typical for the subject's age, in the mid- to lower-facial region or has been diagnosed with a connective tissue disorder.
- Has unphysiological skin laxity or sun damage, beyond typical for the subject's age, or subject plans to tan during the study period.
- Has undergone oral surgery (e.g., orthodontia, extraction, implants) in the past 30 days or plans to receive such surgery during participation in the study.
- Has received mid- and/or lower-facial region treatments with porcine-based collagen fillers, Belotero® Volume, JUVÉDERM VOLUMA®, Restylane® Lyft, RADIESSE®, poly L-lactic acid (PLLA), or mesotherapy within the past 24 months and/or with other hyaluronic acid (HA) products within the past 12 months or plans to receive such treatment during participation in the study.
- Has ever been treated with fat injections or permanent and/or semi-permanent dermal fillers in the mid- and/or lower-facial region or plans to receive such treatment during participation in the study.
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- Has received immunosuppressive medications or systemic steroids (except intranasal/inhaled steroids) in the past 2 months or plans to receive such treatment during participation in the study.
- Has an acute inflammatory process or infection at the injection site (e.g., skin eruptions such as cold sores, cysts, pimples, acne, eczema, hives, streptococcus infections) or history of chronic or recurrent infection or inflammation with the potential to interfere with study results or increase the risk of AEs.
- Has a history of allergic/anaphylactic reactions, including hypersensitivity to lidocaine or anesthetics of the amide type, hyaluronic acid preparations, gram positive bacterial proteins, or any of the device components.
- 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 (e.g., vitamins or herbal supplements, i.e., Vitamin E, garlic, gingko) from 10 days before injection to 3 days after injection.
- Has any other medical condition with the potential to interfere with study outcome assessments or compromise subject safety (i.e., increase the risk of adverse events).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Tennessee Clinical Research Center; Merz Investigational Site #0010097
Nashville, Tennessee, 37215
Research Across America (Synexus); Merz Investigational Site #0010125
Plano, Texas, 75093
Center for Dermatology and Dermatology Surgery; Merz Investigational Site #0010170
Washington D.C., District of Columbia, 20037
About this study
Demonstrate the effectiveness of Belotero Balance with lidocaine (Test group) for the reduction of injection-related pain in comparison to Belotero Balance without lidocaine (Control group) for the correction of NLFs.
Identify and describe adverse events (AEs) and serious adverse events (SAEs) during the course of the study. Additionally, common treatment site responses (CTRs) will be assessed.
- Being tested
- Belotero® Balance with integral lidocaine, Belotero® Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belotero® Balance with integral lidocaineDevice
Also called Hyaluronic acid dermal filler with lidocaine, single use syringe
Mode of application: intradermal injection. Maximum treatment volume: 3 mL per nasolabial fold over two Treatment sessions.
Belotero® BalanceDevice
Also called Hyaluronic acid dermal filler, single use syringe
Mode of application: intradermal injection. Maximum treatment volume: 3 mL per nasolabial fold over two Treatment sessions.
| Study group | Role | What they receive |
|---|---|---|
| Belotero® Balance with integral lidocaine | Experimental | Belotero® Balance with integral lidocaine will be injected in one of the two NLF (split-face study design: treatment side will be randomized) Receives: Device: Belotero® Balance with integral lidocaine |
| Belotero Balance without lidocaine | Active comparator | Belotero Balance without lidocaine will be injected in one of the two NLF (split-face study design: treatment side will be randomized) Receives: Device: Belotero® Balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Pain Using Visual Analog Scale (VAS)
Pain was assessed using a using a 10 centimeter (cm) VAS. It included 21-numbered circles at 0.5 cm increments, spanning 10 cm total, and was anchored by word descriptors. The VAS scores ranged from 0 (no pain) to 10 (very severe pain).The level of pain was evaluated for each NLF independently immediately upon completion of injection (time zero) on Day 1.
Measured: Day 1
Secondary outcomes (5)
Percentage of Responders With Greater Than or Equal to (>=) 1-point Improvement as Evaluated Using Merz NLF Scale at Week 6
The Merz NLF scale was used to measure the aesthetic effectiveness of the study products. Each NLF was assessed separately. The Merz NLF scale is a 5-grade scale ranging from 0 (no folds) to 4 (very severe folds). Response was defined >=1-point improvement on the Merz NLF Scale for each NLF compared to baseline.
Measured: Week 6
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Baseline up to Week 6
Number of Participants With Incidence of Any Common Treatment Site Response (CTR) Evaluated Using Participant Diaries
CTR were evaluated using participant diaries. Participants recorded daily in the diary any pre-defined CTR that occurred. These CTR included swelling, firmness, lumps/bumps, bruising, pain, tenderness upon pressing, redness, discoloration (not redness or bruising), itching, stinging/burning, and numbness.
Measured: Baseline up to Week 6
Number of Participants With Incidence of Any CTR by Severity Evaluated Using Participant Diaries
CTR were evaluated using participant diaries. Participants recorded daily in the diary any pre-defined CTR that occurred. These CTR included swelling, firmness, lumps/bumps, bruising, pain, tenderness upon pressing, redness, discoloration (not redness or bruising), itching, stinging/burning, and numbness.
Measured: Baseline up to Week 6
Number of Participants With Incidence of Any CTR by Duration Evaluated Using Participant Diaries
CTR were evaluated using participant diaries. Participants recorded daily in the diary any pre-defined CTR that occurred. These CTR included swelling, firmness, lumps/bumps, bruising, pain, tenderness upon pressing, redness, discoloration (not redness or bruising), itching, stinging/burning, and numbness.
Measured: Baseline up to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start18 Sep 2017
- Primary completion6 Dec 2017
- Study completion6 Dec 2017
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 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Kreymerman, MD, FACS, Study director, Merz North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319719
- Sponsor's protocol ID
- M930021001
- Status last verified
- Jan 2018
- First submitted
- 4 Oct 2017
- Last updated
- 1 Oct 2019
- 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 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain With Belotero® Balance With Integral Lidocaine for Correction of the Nasolabial Folds
- ClinicalTrials.gov ID
- NCT03319719
- Acronym / sponsor ID
- M930021001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 6 Dec 2017 (actual)
- Study completion
- 6 Dec 2017 (actual)
- First posted
- 24 Oct 2017 (actual)
- Results
- Posted 1 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Demonstrate the effectiveness of Belotero Balance with lidocaine (Test group) for the reduction of injection-related pain in comparison to Belotero Balance without lidocaine (Control group) for the correction of NLFs.
Identify and describe adverse events (AEs) and serious adverse events (SAEs) during the course of the study. Additionally, common treatment site responses (CTRs) will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Belotero® Balance with integral lidocaine | Experimental | Device: Belotero® Balance with integral lidocaineBelotero® Balance with integral lidocaine will be injected in one of the two NLF (split-face study design: treatment side will be randomized) |
| Belotero Balance without lidocaine | Active comparator | Device: Belotero® BalanceBelotero Balance without lidocaine will be injected in one of the two NLF (split-face study design: treatment side will be randomized) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has right and left NLF ratings of 2 or 3 (moderate or severe) on the Merz NLF Scale, as determined by the blinded evaluator.
- Has the same Merz NLF Scale rating on both NLFs (i.e., symmetrical NLFs).
- Is at least 18 years of age.
- Understands and accepts the obligation not to receive any other procedures (i.e., dermal fillers, toxin treatments, facial ablative or fractional laser, microderm abrasion, chemical peels, non-invasive skin-tightening [e.g., Ultherapy, Thermage], or surgical procedures) below the orbital rim on the face during study participation.
Key exclusion criteria (11 listed)
- Had prior surgery in the mid- and/or lower-face area, including the nasolabial fold(s), or has a permanent implant or graft in the mid- and/or lower-face area that could interfere with effectiveness assessments. (NOTE: Rhinoplasty is permitted if the procedure was ≥ 12 months prior to study enrollment.)
- Has skin or fat atrophy, beyond typical for the subject's age, in the mid- to lower-facial region or has been diagnosed with a connective tissue disorder.
- Has unphysiological skin laxity or sun damage, beyond typical for the subject's age, or subject plans to tan during the study period.
- Has undergone oral surgery (e.g., orthodontia, extraction, implants) in the past 30 days or plans to receive such surgery during participation in the study.
- Has received mid- and/or lower-facial region treatments with porcine-based collagen fillers, Belotero® Volume, JUVÉDERM VOLUMA®, Restylane® Lyft, RADIESSE®, poly L-lactic acid (PLLA), or mesotherapy within the past 24 months and/or with other hyaluronic acid (HA) products within the past 12 months or plans to receive such treatment during participation in 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 |
|---|---|---|
| Belotero® Balance with integral lidocaineAlso: Hyaluronic acid dermal filler with lidocaine, single use syringeMode of application: intradermal injection. Maximum treatment volume: 3 mL per nasolabial fold over two Treatment sessions. | Device | Belotero® Balance with integral lidocaine |
| Belotero® BalanceAlso: Hyaluronic acid dermal filler, single use syringeMode of application: intradermal injection. Maximum treatment volume: 3 mL per nasolabial fold over two Treatment sessions. | Device | Belotero Balance without lidocaine |
Primary outcome
Mean Pain Using Visual Analog Scale (VAS)
Time frame: Day 1
Pain was assessed using a using a 10 centimeter (cm) VAS. It included 21-numbered circles at 0.5 cm increments, spanning 10 cm total, and was anchored by word descriptors. The VAS scores ranged from 0 (no pain) to 10 (very severe pain).The level of pain was evaluated for each NLF independently immediately upon completion of injection (time zero) on Day 1.
5 secondary outcomes
Percentage of Responders With Greater Than or Equal to (>=) 1-point Improvement as Evaluated Using Merz NLF Scale at Week 6
Time frame: Week 6
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to Week 6
Number of Participants With Incidence of Any Common Treatment Site Response (CTR) Evaluated Using Participant Diaries
Time frame: Baseline up to Week 6
Number of Participants With Incidence of Any CTR by Severity Evaluated Using Participant Diaries
Time frame: Baseline up to Week 6
Number of Participants With Incidence of Any CTR by Duration Evaluated Using Participant Diaries
Time frame: Baseline up to Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Peter Kreymerman, MD, FACS study director
Merz North America, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Belotero® Balance with integral lidocaine and Belotero® Balance in people with Correction of Moderate to Severe Nasolabial Folds, run by Merz North America, Inc. at 3 sites 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 4 inclusion and 11 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 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 1 Oct 2019). 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?
Mean Pain Using Visual Analog Scale (VAS) (time frame: Day 1). 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 1 Oct 2019.