Nasolabial Folds
Conditions
Keywords
Moderate to severe wrinkles and folds such as nasolabial folds
Brief summary
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
Interventions
DEVICERadiesse® Injectable Dermal Filler with Lidocaine
Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier with 3% lidocaine hydrochloride (HCl)
Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)
Sponsors
Merz North America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score Using a 10-cm Visual Analog Scale (VAS) for Pain (0 = no Pain, 10 = Very Severe Pain) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) Pain Score 15 Minutes Post Injection | 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. |
| Visual Analogue Scale (VAS) Pain Score 30 Minutes Post Injection | 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. |
| Visual Analogue Scale (VAS) Pain Score 45 Minutes Post Injection | 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. |
| Visual Analogue Scale (VAS) Pain Score 60 Minutes Post Injection | 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. |
| Number of Participants With a Clinically Meaningful Reduction in Pain As Defined by a ≥ 2.0-cm Reduction in VAS | Immediately after injection (Time 0) | 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. |
| Visual Analogue Scale (VAS) Pain Score 2 Weeks Post Injection | 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. |
| Visual Analogue Scale (VAS) Pain Score 4 Weeks Post Injection | 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. |
| Assess Subject Preference to Pain | Immediately after injection (Time 0) | 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. |
| Visual Analogue Scale (VAS) Pain Score 1 Week Post Injection | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 102 |
| Total | 102 |
Baseline characteristics
| Characteristic | Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine |
|---|---|
| Age, Customized | 48.85 years STANDARD_DEVIATION 9.43 |
| Fitzpatrick Skin Type I: burns easily, never tans | 6 participants |
| Fitzpatrick Skin Type II: burns easily, tans minimally with difficulty | 19 participants |
| Fitzpatrick Skin Type III: burns moderately, tans moderately & uniformly | 59 participants |
| Fitzpatrick Skin Type IV: burns minimally, tans moderately & easily | 8 participants |
| Fitzpatrick Skin Type VI: never burns, tans profusely | 5 participants |
| Fitzpatrick Skin Type V: rarely burns, tans profusely | 5 participants |
| Race/Ethnicity, Customized African American | 8 participants |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Caucasian | 88 participants |
| Race/Ethnicity, Customized Hispanic | 2 participants |
| Race/Ethnicity, Customized Other | 3 participants |
| Region of Enrollment Canada | 102 participants |
| Sex: Female, Male Female | 87 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 90 / 101 | 92 / 101 |
| serious Total, serious adverse events | 0 / 101 | 0 / 101 |
Outcome results
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.
Time frame: Immediately after injection (Time 0)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiesse® Mixed With Lidocaine | Pain Score Using a 10-cm Visual Analog Scale (VAS) for Pain (0 = no Pain, 10 = Very Severe Pain) | 2.32 units on a scale | Standard Deviation 1.57 |
| Radiesse® Without Lidocaine | Pain Score Using a 10-cm Visual Analog Scale (VAS) for Pain (0 = no Pain, 10 = Very Severe Pain) | 6.73 units on a scale | Standard Deviation 2.22 |
p-value: <0.0001t-test, 2 sided
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.
Time frame: Immediately after injection (Time 0)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radiesse® Mixed With Lidocaine | Assess Subject Preference to Pain | Was One Treatment Less Painful Than the Other? | 98 participants responding yes |
| Radiesse® Mixed With Lidocaine | Assess Subject Preference to Pain | Pain Significant Enough to Affect Preference? | 87 participants responding yes |
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.
Time frame: Immediately after injection (Time 0)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiesse® Mixed With Lidocaine | Number of Participants With a Clinically Meaningful Reduction in Pain As Defined by a ≥ 2.0-cm Reduction in VAS | 91 participants |
Comparison: 91 (90.1%) of 101 subjects had a ≥ 2.0 cm lower VAS Score in treatment versus control NLF at Time 0p-value: <0.0001Fisher Exact
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.
Time frame: 15 minutes post injection
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiesse® Mixed With Lidocaine | Visual Analogue Scale (VAS) Pain Score 15 Minutes Post Injection | 1.06 units on a scale | Standard Deviation 1.23 |
| Radiesse® Without Lidocaine | Visual Analogue Scale (VAS) Pain Score 15 Minutes Post Injection | 3.45 units on a scale | Standard Deviation 2.31 |
p-value: <0.0001t-test, 2 sided
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.
Time frame: 1 week post injection
Population: Two subjects missed their Week 1 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiesse® Mixed With Lidocaine | Visual Analogue Scale (VAS) Pain Score 1 Week Post Injection | 0.05 units on a scale | Standard Deviation 0.32 |
| Radiesse® Without Lidocaine | Visual Analogue Scale (VAS) Pain Score 1 Week Post Injection | 0.04 units on a scale | Standard Deviation 0.31 |
p-value: 0.5663t-test, 2 sided
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.
Time frame: 2 weeks post injection
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiesse® Mixed With Lidocaine | Visual Analogue Scale (VAS) Pain Score 2 Weeks Post Injection | 0.01 units on a scale | Standard Deviation 0 |
| Radiesse® Without Lidocaine | Visual Analogue Scale (VAS) Pain Score 2 Weeks Post Injection | 0 units on a scale | Standard Deviation 0 |
p-value: 0.3197t-test, 2 sided
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.
Time frame: 30 minutes post injection
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiesse® Mixed With Lidocaine | Visual Analogue Scale (VAS) Pain Score 30 Minutes Post Injection | 0.73 units on a scale | Standard Deviation 0.99 |
| Radiesse® Without Lidocaine | Visual Analogue Scale (VAS) Pain Score 30 Minutes Post Injection | 2.52 units on a scale | Standard Deviation 2.35 |
p-value: <0.0001t-test, 2 sided
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.
Time frame: 45 minutes post injection
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiesse® Mixed With Lidocaine | Visual Analogue Scale (VAS) Pain Score 45 Minutes Post Injection | 0.48 units on a scale | Standard Deviation 0.78 |
| Radiesse® Without Lidocaine | Visual Analogue Scale (VAS) Pain Score 45 Minutes Post Injection | 1.78 units on a scale | Standard Deviation 2 |
p-value: <0.0001t-test, 2 sided
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.
Time frame: 4 weeks post injection
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiesse® Mixed With Lidocaine | Visual Analogue Scale (VAS) Pain Score 4 Weeks Post Injection | 0 units on a scale | Standard Deviation 0 |
| Radiesse® Without Lidocaine | Visual Analogue Scale (VAS) Pain Score 4 Weeks Post Injection | 0 units on a scale | Standard Deviation 0 |
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.
Time frame: 60 minutes post injection
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiesse® Mixed With Lidocaine | Visual Analogue Scale (VAS) Pain Score 60 Minutes Post Injection | 0.31 units on a scale | Standard Deviation 0.66 |
| Radiesse® Without Lidocaine | Visual Analogue Scale (VAS) Pain Score 60 Minutes Post Injection | 1.09 units on a scale | Standard Deviation 1.56 |
p-value: <0.0001t-test, 2 sided