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To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler mixed with lidocaine.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiesse® Injectable Dermal Filler Mixed with Lidocaine | Device | Calcium hydroxylapatite particles suspended in an aqueous based gel carrier mixed with 2% lidocaine hydrochloride (HCl) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | Immediately after injection (Time 0) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rockville | Maryland | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20100272 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiesse® Mixed With Lidocaine & Radiesse® Without Lidocaine | Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl) and Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl). The same 50 participants received both the treatment device and the control device at the same time (left and right sides of face). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine | Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl) and Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | cm | Immediately after injection (Time 0) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radiesse® Mixed With Lidocaine | Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruising | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merz Aesthetics, Inc. | Merz Aesthetics, Inc. | 650-286-4041 | clinicaltrials@merzaesthetics.com |
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| Radiesse® Injectable Dermal Filler without Lidocaine | Device | Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl) |
|
| New York |
| New York |
| United States |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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). | Posted | Number | Participants | Immediately after injection (Time 0) |
|
|
|
| 0 |
| 50 |
| 46 |
| 50 |
| EG001 | Radiesse® Without Lidocaine | Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl) | 0 | 50 | 45 | 50 |
| Itching | Skin and subcutaneous tissue disorders |
|
| Pain | Skin and subcutaneous tissue disorders |
|
| Redness | Skin and subcutaneous tissue disorders |
|
| Swelling | Skin and subcutaneous tissue disorders |
|
Sponsor reserves right to review/comment on any manuscript for publication/presentation presenting data from the trial. No manuscript may be submitted for publication without prior review. Investigator agrees to accommodate reasonable requests to protect propriety rights/interests. Investigator must ensure accuracy of results. Investigator shall grant Sponsor right to reproduce/translate/use all copyrighted material from study publications.