Trial Outcomes & Findings for Evaluation of Pain With Radiesse® With Lidocaine for Nasolabial Folds (NCT NCT01069354)
NCT ID: NCT01069354
Last Updated: 2018-05-30
Results Overview
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.
COMPLETED
NA
102 participants
Immediately after injection (Time 0)
2018-05-30
Participant Flow
Participant milestones
| Measure |
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)
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
101
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Pain With Radiesse® With Lidocaine for Nasolabial Folds
Baseline characteristics by cohort
| Measure |
Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine
n=102 Participants
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)
|
|---|---|
|
Age, Customized
|
48.85 years
STANDARD_DEVIATION 9.43 • n=99 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
88 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
African American
|
8 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=99 Participants
|
|
Region of Enrollment
Canada
|
102 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
I: burns easily, never tans
|
6 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
II: burns easily, tans minimally with difficulty
|
19 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
III: burns moderately, tans moderately & uniformly
|
59 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
IV: burns minimally, tans moderately & easily
|
8 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
V: rarely burns, tans profusely
|
5 participants
n=99 Participants
|
|
Fitzpatrick Skin Type
VI: never burns, tans profusely
|
5 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Radiesse® Mixed With Lidocaine
n=101 Nasolabial folds
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)
|
Radiesse® Without Lidocaine
n=101 Nasolabial folds
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)
|
|---|---|---|
|
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
|
6.73 units on a scale
Standard Deviation 2.22
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Radiesse® Mixed With Lidocaine
n=101 Participants
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)
|
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)
|
|---|---|---|
|
Number of Participants With a Clinically Meaningful Reduction in Pain As Defined by a ≥ 2.0-cm Reduction in VAS
|
91 participants
|
—
|
SECONDARY outcome
Timeframe: 15 minutes post injectionPopulation: 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.
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.
Outcome measures
| Measure |
Radiesse® Mixed With Lidocaine
n=101 Participants
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)
|
Radiesse® Without Lidocaine
n=101 Participants
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)
|
|---|---|---|
|
Visual Analogue Scale (VAS) Pain Score 15 Minutes Post Injection
|
1.06 units on a scale
Standard Deviation 1.23
|
3.45 units on a scale
Standard Deviation 2.31
|
SECONDARY outcome
Timeframe: 30 minutes post injectionPopulation: 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.
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.
Outcome measures
| Measure |
Radiesse® Mixed With Lidocaine
n=101 Participants
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)
|
Radiesse® Without Lidocaine
n=101 Participants
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)
|
|---|---|---|
|
Visual Analogue Scale (VAS) Pain Score 30 Minutes Post Injection
|
0.73 units on a scale
Standard Deviation 0.99
|
2.52 units on a scale
Standard Deviation 2.35
|
SECONDARY outcome
Timeframe: 45 minutes post injectionPopulation: 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.
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.
Outcome measures
| Measure |
Radiesse® Mixed With Lidocaine
n=101 Participants
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)
|
Radiesse® Without Lidocaine
n=101 Participants
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)
|
|---|---|---|
|
Visual Analogue Scale (VAS) Pain Score 45 Minutes Post Injection
|
0.48 units on a scale
Standard Deviation 0.78
|
1.78 units on a scale
Standard Deviation 2.00
|
SECONDARY outcome
Timeframe: 60 minutes post injectionPopulation: 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.
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.
Outcome measures
| Measure |
Radiesse® Mixed With Lidocaine
n=101 Participants
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)
|
Radiesse® Without Lidocaine
n=101 Participants
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)
|
|---|---|---|
|
Visual Analogue Scale (VAS) Pain Score 60 Minutes Post Injection
|
0.31 units on a scale
Standard Deviation 0.66
|
1.09 units on a scale
Standard Deviation 1.56
|
SECONDARY outcome
Timeframe: 1 week post injectionPopulation: Two subjects missed their Week 1 visit.
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.
Outcome measures
| Measure |
Radiesse® Mixed With Lidocaine
n=99 Participants
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)
|
Radiesse® Without Lidocaine
n=99 Participants
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)
|
|---|---|---|
|
Visual Analogue Scale (VAS) Pain Score 1 Week Post Injection
|
0.05 units on a scale
Standard Deviation 0.32
|
0.04 units on a scale
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: 2 weeks post injectionPopulation: 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.
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.
Outcome measures
| Measure |
Radiesse® Mixed With Lidocaine
n=101 Participants
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)
|
Radiesse® Without Lidocaine
n=101 Participants
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)
|
|---|---|---|
|
Visual Analogue Scale (VAS) Pain Score 2 Weeks Post Injection
|
0.01 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 4 weeks post injectionPopulation: 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.
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.
Outcome measures
| Measure |
Radiesse® Mixed With Lidocaine
n=101 Participants
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)
|
Radiesse® Without Lidocaine
n=101 Participants
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)
|
|---|---|---|
|
Visual Analogue Scale (VAS) Pain Score 4 Weeks Post Injection
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Radiesse® Mixed With Lidocaine
n=101 Participants
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)
|
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)
|
|---|---|---|
|
Assess Subject Preference to Pain
Was One Treatment Less Painful Than the Other?
|
98 participants responding "yes"
|
—
|
|
Assess Subject Preference to Pain
Pain Significant Enough to Affect Preference?
|
87 participants responding "yes"
|
—
|
Adverse Events
Radiesse® Mixed With Lidocaine
Radiesse® Without Lidocaine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Radiesse® Mixed With Lidocaine
n=101 participants at risk
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)
|
Radiesse® Without Lidocaine
n=101 participants at risk
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)
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Bruising
|
43.6%
44/101 • Number of events 44
|
47.5%
48/101 • Number of events 48
|
|
Skin and subcutaneous tissue disorders
Itching
|
36.6%
37/101 • Number of events 37
|
33.7%
34/101 • Number of events 34
|
|
Skin and subcutaneous tissue disorders
Pain
|
47.5%
48/101 • Number of events 48
|
56.4%
57/101 • Number of events 57
|
|
Skin and subcutaneous tissue disorders
Redness
|
65.3%
66/101 • Number of events 66
|
70.3%
71/101 • Number of events 71
|
|
Skin and subcutaneous tissue disorders
Swelling
|
89.1%
90/101 • Number of events 90
|
91.1%
92/101 • Number of events 92
|
|
Skin and subcutaneous tissue disorders
Blanching
|
5.0%
5/101 • Number of events 5
|
7.9%
8/101 • Number of events 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place