Trial Outcomes & Findings for Evaluation of Pain With Lidocaine-Mixed Radiesse® Injectable Dermal Filler (NCT NCT01012661)
NCT ID: NCT01012661
Last Updated: 2013-04-26
Results Overview
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).
COMPLETED
PHASE4
50 participants
Immediately after injection (Time 0)
2013-04-26
Participant Flow
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Pain With Lidocaine-Mixed Radiesse® Injectable Dermal Filler
Baseline characteristics by cohort
| Measure |
Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine
n=50 Participants
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)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=93 Participants
|
|
Age Continuous
|
53 years
STANDARD_DEVIATION 10.1 • n=93 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Radiesse® Mixed With Lidocaine
n=50 Participants
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl)
|
Radiesse® Without Lidocaine
n=50 Participants
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
|
|---|---|---|
|
Pain Score Using a 10-cm Visual Analog Pain Scale (1 = no Pain, 10 = Very Severe Pain)
|
2.8 cm
Standard Deviation 1.9
|
6.6 cm
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Radiesse® Mixed With Lidocaine
n=50 Participants
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl)
|
Radiesse® Without Lidocaine
n=50 Participants
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
|
|---|---|---|
|
Patients With Clinically Significant Reduction in Pain
|
45 Participants
|
0 Participants
|
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=50 participants at risk
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl)
|
Radiesse® Without Lidocaine
n=50 participants at risk
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Bruising
|
50.0%
25/50 • Number of events 26
|
50.0%
25/50 • Number of events 25
|
|
Skin and subcutaneous tissue disorders
Itching
|
20.0%
10/50 • Number of events 13
|
24.0%
12/50 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Pain
|
42.0%
21/50 • Number of events 22
|
46.0%
23/50 • Number of events 25
|
|
Skin and subcutaneous tissue disorders
Redness
|
56.0%
28/50 • Number of events 29
|
60.0%
30/50 • Number of events 32
|
|
Skin and subcutaneous tissue disorders
Swelling
|
88.0%
44/50 • Number of events 47
|
84.0%
42/50 • Number of events 44
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER