Nasolabial FoldsNCT01069354
Evaluation of Pain With Radiesse® With Lidocaine for Nasolabial Folds
A study testing Radiesse® Injectable Dermal Filler with Lidocaine and Radiesse® Injectable Dermal Filler without Lidocaine in people with Nasolabial Folds, run by Merz North America, Inc. at 2 sites in Canada.
Trial summary
To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler with lidocaine Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Folds
- What is being tested?
- Radiesse® Injectable Dermal Filler with Lidocaine and Radiesse® Injectable Dermal Filler without Lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2012to Feb 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is at least 18 years of age
- Is a candidate for nasolabial fold treatment using Radiesse
- Has approximately symmetrical nasolabial folds
- Understands and accepts the obligation not to receive any other facial procedures in the lower half of the face for 1 month
Who cannot join
- Has received any type of treatment or procedures including surgery in the nasolabial folds
- Has received neurotoxin, hyaluronic acid, calcium hydroxylapatite (CaHA) or collagen injections in the lower half of the face within past 6 months
- Has received polylactic acid, polymethyl methacrylate (PMMA), silicone or any other permanent filler in the lower half of the face
- Has nasolabial folds that are too severe to be corrected in one treatment session
- Has any history of hypersensitivity to lidocaine or anesthetics of the amide type
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Evaluation of Pain With the Use of Radiesse® With Lidocaine for the Treatment of Nasolabial Folds
To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler with lidocaine
Read the detailed description
To assess pain immediately after nasolabial fold treatment with Radiesse® Injectable Dermal Filler with lidocaine in one nasolabial fold compared to Radiesse® Injectable Dermal Filler without lidocaine in the contralateral nasolabial fold
- Conditions
- Nasolabial Folds
- Being tested
- Radiesse® Injectable Dermal Filler with Lidocaine, Radiesse® Injectable Dermal Filler without Lidocaine
- Keywords
- Moderate to severe wrinkles and folds such as nasolabial folds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiesse® Injectable Dermal Filler with LidocaineDevice
Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier with 3% lidocaine hydrochloride (HCl)
Radiesse® Injectable Dermal Filler without LidocaineDevice
Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)
| Study group | Role | What they receive |
|---|---|---|
| Radiesse® Mixed with Lidocaine | Experimental | Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face). Receives: Device: Radiesse® Injectable Dermal Filler with Lidocaine |
| Radiesse® without Lidocaine | Active comparator | Injectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face). Receives: Device: Radiesse® Injectable Dermal Filler without Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score Using a 10-cm Visual Analog Scale (VAS) for Pain (0 = no Pain, 10 = Very Severe Pain)
Assessment of whether a statistically significant reduction in pain score in the Radiesse® Mixed with Lidocaine nasolabial fold was observed when compared to the Radiesse® without Lidocaine nasolabial fold using a 10-cm visual analog pain scale (0 = no pain, 10 = very severe pain).
In the study protocol, the assessment of achieving a statistically significant reduction in pain at time zero was selected a priori to be analyzed using a paired t-test to test the null hypothesis that the mean of the differences in VAS scores between the Treatment and Control folds is equal to zero.
Measured: Immediately after injection (Time 0)
Secondary outcomes (9)
Number of Participants With a Clinically Meaningful Reduction in Pain As Defined by a ≥ 2.0-cm Reduction in VAS
In this split-face study, a clinically meaningful difference in pain was defined as a 2-cm "reduction" (i.e., subject reports at least 2-cm less pain on a 10-cm VAS) in the Radiesse® Mixed with Lidocaine NLF when compared to the Radiesse® without Lidocaine NLF.
Measured: Immediately after injection (Time 0)
Visual Analogue Scale (VAS) Pain Score 15 Minutes Post Injection
A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.
Measured: 15 minutes post injection
Visual Analogue Scale (VAS) Pain Score 30 Minutes Post Injection
A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.
Measured: 30 minutes post injection
Visual Analogue Scale (VAS) Pain Score 45 Minutes Post Injection
A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.
Measured: 45 minutes post injection
Visual Analogue Scale (VAS) Pain Score 60 Minutes Post Injection
A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.
Measured: 60 minutes post injection
Visual Analogue Scale (VAS) Pain Score 1 Week Post Injection
A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.
Measured: 1 week post injection
Visual Analogue Scale (VAS) Pain Score 2 Weeks Post Injection
A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.
Measured: 2 weeks post injection
Visual Analogue Scale (VAS) Pain Score 4 Weeks Post Injection
A 10-cm VAS (with 21 total circles, marked at 0.5 cm intervals) was used in which 0 = no pain and 10 = very severe pain.
Measured: 4 weeks post injection
Assess Subject Preference to Pain
2 questions were asked of 101 subjects: 1) Was one treatment less painful than the other? and 2) Was the difference in pain levels significant enough to affect your preference for one treatment over the other?
Only those participants responding "yes" to these 2 questions about pain and preference for treatment are reported in the table below.
Measured: Immediately after injection (Time 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- Study completionFeb 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fred Derosier, DO, Study director, Merz North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069354
- Sponsor's protocol ID
- P120677
- Status last verified
- Sep 2017
- First submitted
- 15 Feb 2010
- Last updated
- 30 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Schachter D, Bertucci V, Solish N. Calcium Hydroxylapatite With Integral Lidocaine Provides Improved Pain Control for the Correction of Nasolabial Folds. J Drugs Dermatol. 2016 Aug 1;15(8):1005-10.
PubMed 27538003
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain With the Use of Radiesse® With Lidocaine for the Treatment of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT01069354
- Acronym / sponsor ID
- P120677
- Conditions
- Nasolabial Folds
- Keywords
- Moderate to severe wrinkles and folds such as nasolabial folds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Posted 30 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler with lidocaine
Detailed description
To assess pain immediately after nasolabial fold treatment with Radiesse® Injectable Dermal Filler with lidocaine in one nasolabial fold compared to Radiesse® Injectable Dermal Filler without lidocaine in the contralateral nasolabial fold
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiesse® Mixed with Lidocaine | Experimental | Device: Radiesse® Injectable Dermal Filler with LidocaineInjectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face). |
| Radiesse® without Lidocaine | Active comparator | Device: Radiesse® Injectable Dermal Filler without LidocaineInjectable Dermal Filler. The same participants received the experimental device and the active comparator device at the same time (left and right sides of face). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Is at least 18 years of age
- Is a candidate for nasolabial fold treatment using Radiesse
- Has approximately symmetrical nasolabial folds
- Understands and accepts the obligation not to receive any other facial procedures in the lower half of the face for 1 month
Key exclusion criteria (5 listed)
- Has received any type of treatment or procedures including surgery in the nasolabial folds
- Has received neurotoxin, hyaluronic acid, calcium hydroxylapatite (CaHA) or collagen injections in the lower half of the face within past 6 months
- Has received polylactic acid, polymethyl methacrylate (PMMA), silicone or any other permanent filler in the lower half of the face
- Has nasolabial folds that are too severe to be corrected in one treatment session
- Has any history of hypersensitivity to lidocaine or anesthetics of the amide type
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 Dermal Filler with LidocaineCalcium hydroxylapatite particles suspended in an aqueous-based gel carrier with 3% lidocaine hydrochloride (HCl) | Device | Radiesse® Mixed with Lidocaine |
| Radiesse® Injectable Dermal Filler without LidocaineCalcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl) | Device | Radiesse® without Lidocaine |
Primary outcome
Pain Score Using a 10-cm Visual Analog Scale (VAS) for Pain (0 = no Pain, 10 = Very Severe Pain)
Time frame: Immediately after injection (Time 0)
Assessment of whether a statistically significant reduction in pain score in the Radiesse® Mixed with Lidocaine nasolabial fold was observed when compared to the Radiesse® without Lidocaine nasolabial fold using a 10-cm visual analog pain scale (0 = no pain, 10 = very severe pain). In the study protocol, the assessment of achieving a statistically significant reduction in pain at time zero was selected a priori to be analyzed using a paired t-test to test the null hypothesis that the mean of the differences in VAS scores between the Treatment and Control folds is equal to zero.
9 secondary outcomes
Number of Participants With a Clinically Meaningful Reduction in Pain As Defined by a ≥ 2.0-cm Reduction in VAS
Time frame: Immediately after injection (Time 0)
Visual Analogue Scale (VAS) Pain Score 15 Minutes Post Injection
Time frame: 15 minutes post injection
Visual Analogue Scale (VAS) Pain Score 30 Minutes Post Injection
Time frame: 30 minutes post injection
Visual Analogue Scale (VAS) Pain Score 45 Minutes Post Injection
Time frame: 45 minutes post injection
Visual Analogue Scale (VAS) Pain Score 60 Minutes Post Injection
Time frame: 60 minutes post injection
Visual Analogue Scale (VAS) Pain Score 1 Week Post Injection
Time frame: 1 week post injection
Visual Analogue Scale (VAS) Pain Score 2 Weeks Post Injection
Time frame: 2 weeks post injection
Visual Analogue Scale (VAS) Pain Score 4 Weeks Post Injection
Time frame: 4 weeks post injection
Assess Subject Preference to Pain
Time frame: Immediately after injection (Time 0)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27538003Schachter D, Bertucci V, Solish N. Calcium Hydroxylapatite With Integral Lidocaine Provides Improved Pain Control for the Correction of Nasolabial Folds. J Drugs Dermatol. 2016 Aug 1;15(8):1005-10.
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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.
Fred Derosier, DO study director
Merz North America, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiesse® Injectable Dermal Filler with Lidocaine and Radiesse® Injectable Dermal Filler without Lidocaine in people with Nasolabial Folds, run by Merz North America, Inc. at 2 sites in Canada.
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 5 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 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 30 May 2018). 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?
Pain Score Using a 10-cm Visual Analog Scale (VAS) for Pain (0 = no Pain, 10 = Very Severe Pain) (time frame: Immediately after injection (Time 0)). 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 NCT01069354, 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 30 May 2018.