Nasolabial FoldsPhase 4NCT01012661
Evaluation of Pain With Lidocaine-Mixed Radiesse® Injectable Dermal Filler
A Phase 4 study testing Radiesse® Injectable Dermal Filler Mixed with Lidocaine and Radiesse® Injectable Dermal Filler without Lidocaine in people with Nasolabial Folds, run by Merz North America, Inc. at 2 sites in United States.
Trial summary
To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler mixed 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 Mixed 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
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2008to Jan 2009
- Phase
- Phase 4
- 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.
- Understands and accepts the obligation not to receive any other facial procedures in the lower half of the face for 1 month.
- Understands and accepts the obligation to present for all scheduled follow-up visits and is logistically able to meet all study requirements.
- Has approximately symmetrical nasolabial folds.
Who cannot join
- Has received any type of treatment or procedures including surgery in the nasolabial folds.
- Has received neurotoxins in the lower half of the face in the past 6 months.
- Has received hyaluronic acid, calcium hydroxylapatite (CaHA) or collagen injections in the lower half of the face within past 1 ½ years.
- 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 a history of chronic or recurrent infection or inflammation that would preclude participation in the study.
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- Has a known bleeding disorder or is receiving medication that will likely increase the risk of bleeding.
- Is female and of child bearing potential and is pregnant or not using acceptable method of birth control.
- Has had any history of hypersensitivity to Lidocaine or anesthetics of the amide type.
- Has a history of anaphylaxis or multiple severe allergies.
- Has received any investigational product within 30 days prior to study enrollment or is planning to participate in another investigation during the course of this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
New York, New York
Study site
Rockville, Maryland
About this study
Official title: Evaluation of Pain With the Use of Lidocaine-Mixed Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds
To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler mixed with lidocaine.
Read the detailed description
To assess pain immediately after nasolabial fold treatment with Radiesse® Injectable Dermal Filler mixed 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 Mixed 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 Mixed with LidocaineDevice
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier mixed with 2% lidocaine hydrochloride (HCl)
Radiesse® Injectable Dermal Filler without LidocaineDevice
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
| Study group | Role | What they receive |
|---|---|---|
| Radiesse® Mixed with Lidocaine | Experimental | Injectable Dermal Filler. The same 50 participants received both the treatment device and the control device at the same time (left and right sides of face). Receives: Device: Radiesse® Injectable Dermal Filler Mixed with Lidocaine |
| Radiesse® without Lidocaine | Active comparator | Injectable Dermal Filler. The same 50 participants received both the treatment device and the control 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 Pain Scale (1 = no Pain, 10 = Very Severe Pain)
Assessment of difference in pain score in the Radiesse Dermal Filler Mixed with Lidocaine nasolabial fold v. the Radiesse Dermal Filler without Lidocaine nasolabial fold using a 10-cm visual analog pain scale (1 = no pain, 10 = very severe pain).
Measured: Immediately after injection (Time 0)
Patients With Clinically Significant Reduction in Pain
Assessment of clinical significance of pain reduction in the Radiesse Injectable Dermal Filler Mixed with Lidocaine nasolabial fold v. Radiesse Injectable Dermal Filler without Lidocaine nasolabial fold defined as number of participants with >/= 2cm difference on a visual analog pain scale (1 = no pain, 10 = very severe pain).
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 posted13 Nov 2009 (estimated)
- Study startSep 2008
- Primary completionDec 2008
- Study completionJan 2009
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012661
- Sponsor's protocol ID
- P0408329
- Status last verified
- Apr 2013
- First submitted
- 10 Nov 2009
- Last updated
- 26 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Marmur E, Green L, Busso M. Controlled, randomized study of pain levels in subjects treated with calcium hydroxylapatite premixed with lidocaine for correction of nasolabial folds. Dermatol Surg. 2010 Mar;36(3):309-15. doi: 10.1111/j.1524-4725.2009.01435.x. Epub 2010 Jan 19.
PubMed 20100272
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain With the Use of Lidocaine-Mixed Radiesse® Injectable Dermal Filler for the Treatment of Nasolabial Folds
- ClinicalTrials.gov ID
- NCT01012661
- Acronym / sponsor ID
- P0408329
- Conditions
- Nasolabial Folds
- Keywords
- Moderate to severe wrinkles and folds such as nasolabial folds
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Posted 15 Jan 2010
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 mixed with lidocaine.
Detailed description
To assess pain immediately after nasolabial fold treatment with Radiesse® Injectable Dermal Filler mixed 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 Mixed with LidocaineInjectable Dermal Filler. The same 50 participants received both the treatment device and the control 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 50 participants received both the treatment device and the control 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 (5 listed)
- Is at least 18 years of age.
- Is a candidate for nasolabial fold treatment using Radiesse.
- Understands and accepts the obligation not to receive any other facial procedures in the lower half of the face for 1 month.
- Understands and accepts the obligation to present for all scheduled follow-up visits and is logistically able to meet all study requirements.
- Has approximately symmetrical nasolabial folds.
Key exclusion criteria (11 listed)
- Has received any type of treatment or procedures including surgery in the nasolabial folds.
- Has received neurotoxins in the lower half of the face in the past 6 months.
- Has received hyaluronic acid, calcium hydroxylapatite (CaHA) or collagen injections in the lower half of the face within past 1 ½ years.
- 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.
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 Mixed with LidocaineCalcium hydroxylapatite particles suspended in an aqueous based gel carrier mixed with 2% lidocaine hydrochloride (HCl) | Device | Radiesse® Mixed with Lidocaine |
| Radiesse® Injectable Dermal Filler without LidocaineCalcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl) | Device | Radiesse® without Lidocaine |
Primary outcome
Pain Score Using a 10-cm Visual Analog Pain Scale (1 = no Pain, 10 = Very Severe Pain)
Time frame: Immediately after injection (Time 0)
Assessment of difference in pain score in the Radiesse Dermal Filler Mixed with Lidocaine nasolabial fold v. the Radiesse Dermal Filler without Lidocaine nasolabial fold using a 10-cm visual analog pain scale (1 = no pain, 10 = very severe pain).
Patients With Clinically Significant Reduction in Pain
Time frame: Immediately after injection (Time 0)
Assessment of clinical significance of pain reduction in the Radiesse Injectable Dermal Filler Mixed with Lidocaine nasolabial fold v. Radiesse Injectable Dermal Filler without Lidocaine nasolabial fold defined as number of participants with >/= 2cm difference on a visual analog pain scale (1 = no pain, 10 = very severe pain).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20100272Marmur E, Green L, Busso M. Controlled, randomized study of pain levels in subjects treated with calcium hydroxylapatite premixed with lidocaine for correction of nasolabial folds. Dermatol Surg. 2010 Mar;36(3):309-15. doi: 10.1111/j.1524-4725.2009.01435.x. Epub 2010 Jan 19.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Radiesse® Injectable Dermal Filler Mixed with Lidocaine and Radiesse® Injectable Dermal Filler without Lidocaine in people with Nasolabial Folds, run by Merz North America, Inc. at 2 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 5 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 26 Apr 2013. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jan 2010). 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 Pain Scale (1 = no Pain, 10 = Very Severe Pain) (time frame: Immediately after injection (Time 0)). The study lists 2 primary outcomes in all. 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 NCT01012661, 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 26 Apr 2013.