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To assess pain during nasolabial fold treatment using Radiesse® Injectable Dermal Filler with lidocaine
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiesse® Injectable Dermal Filler with Lidocaine | Device | Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier with 3% lidocaine hydrochloride (HCl) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after injection (Time 0) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately after injection (Time 0) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fred Derosier, DO | Merz North America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto | Canada | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27538003 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine | Injectable Dermal Filler. The same 102 participants received the experimental device and the active comparator device at the same time (left and right sides of face). Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier containing 3% lidocaine hydrochloride (HCl) and Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine | Injectable Dermal Filler. The same 102 participants received the experimental device and the active comparator device at the same time (left and right sides of face). Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier containing 3% lidocaine hydrochloride (HCl) and Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| 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 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. | Posted | Mean | Standard Deviation | units on a scale | Immediately after injection (Time 0) | Nasolabial folds | Nasolabial folds |
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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 | 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). Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier containing 3% 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 | |
|---|---|---|---|---|
| Ashlee Duncan | Merz North America, Inc. | 984-222-6040 | ashlee.duncan@merz.com |
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| Radiesse® Injectable Dermal Filler without Lidocaine | Device | Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl) |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Immediately after injection (Time 0) |
| Woodbridge |
| Canada |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Fitzpatrick Skin Type | The Fitzpatrick Skin Types (FST) represent a standard classification of skin color based on one's response to sun exposure (i.e., burns or tans), rather than defined by race or ethnicity. All FST were eligible for participation in the current study. See full FST descriptions in Astner S, Anderson RR. Skin phototypes 2003. J Invest Dermatol. 2004 Feb;122(2):xxx-xxxi. | Number | participants |
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| OG001 | Radiesse® Without Lidocaine | 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). Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl) |
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| Secondary | 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. | In this split-face study, participants received both treatments (i.e., 1 NLF with Radiesse Mixed with Lidocaine and 1 NLF with Radiesse without Lidocaine). Results are presented as the number of participants reporting at least a 2-cm lower pain VAS score in the Radiesse Mixed with Lidocaine NLF when compared to the Radiesse without Lidocaine NLF. | Posted | Number | participants | Immediately after injection (Time 0) |
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| Secondary | 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. | One subject did not receive treatment in the Radiesse® Mixed with Lidocaine (treatment) fold due to adverse event during injection of the Radiesse® without Lidocaine (control) nasolabial fold, which was randomized to be treated first. This subject was followed through the end of the trial for safety, but was excluded from comparative analyses. | Posted | Mean | Standard Deviation | units on a scale | 15 minutes post injection |
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| Secondary | 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. | One subject did not receive treatment in the Radiesse® Mixed with Lidocaine (treatment) fold due to adverse event during injection of the Radiesse® without Lidocaine (control) nasolabial fold, which was randomized to be treated first. This subject was followed through the end of the trial for safety, but was excluded from comparative analyses. | Posted | Mean | Standard Deviation | units on a scale | 30 minutes post injection |
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| Secondary | 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. | One subject did not receive treatment in the Radiesse® Mixed with Lidocaine (treatment) fold due to adverse event during injection of the Radiesse® without Lidocaine (control) nasolabial fold, which was randomized to be treated first. This subject was followed through the end of the trial for safety, but was excluded from comparative analyses. | Posted | Mean | Standard Deviation | units on a scale | 45 minutes post injection |
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| Secondary | 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. | One subject did not receive treatment in the Radiesse® Mixed with Lidocaine (treatment) fold due to adverse event during injection of the Radiesse® without Lidocaine (control) nasolabial fold, which was randomized to be treated first. This subject was followed through the end of the trial for safety, but was excluded from comparative analyses. | Posted | Mean | Standard Deviation | units on a scale | 60 minutes post injection |
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| Secondary | 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. | Two subjects missed their Week 1 visit. | Posted | Mean | Standard Deviation | units on a scale | 1 week post injection |
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| Secondary | 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. | One subject did not receive treatment in the Radiesse® Mixed with Lidocaine (treatment) fold due to adverse event during injection of the Radiesse® without Lidocaine (control) nasolabial fold, which was randomized to be treated first. This subject was followed through the end of the trial for safety, but was excluded from comparative analyses. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks post injection |
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| Secondary | 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. | One subject did not receive treatment in the Radiesse® Mixed with Lidocaine (treatment) fold due to adverse event during injection of the Radiesse® without Lidocaine (control) nasolabial fold, which was randomized to be treated first. This subject was followed through the end of the trial for safety, but was excluded from comparative analyses. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks post injection |
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| Secondary | 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. | Posted | Number | participants responding "yes" | Immediately after injection (Time 0) |
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| 0 |
| 101 |
| 90 |
| 101 |
| EG001 | Radiesse® Without Lidocaine | 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). Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl) | 0 | 101 | 92 | 101 |
| Itching | Skin and subcutaneous tissue disorders |
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| Pain | Skin and subcutaneous tissue disorders |
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| Redness | Skin and subcutaneous tissue disorders |
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| Swelling | Skin and subcutaneous tissue disorders |
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| Blanching | Skin and subcutaneous tissue disorders |
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