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Evaluation of Pain With Lidocaine-Mixed Radiesse® Injectable Dermal Filler

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ClinicalTrials.gov Identifier: NCT01012661
Recruitment Status : Completed
First Posted : November 13, 2009
Results First Posted : January 15, 2010
Last Update Posted : April 26, 2013
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Nasolabial Folds
Interventions Device: Radiesse® Injectable Dermal Filler Mixed with Lidocaine
Device: Radiesse® Injectable Dermal Filler without Lidocaine
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Radiesse® Mixed With Lidocaine & Radiesse® Without Lidocaine
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 50
Completed 50
Not Completed 0
Arm/Group Title Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine
Hide Arm/Group Description 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)
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
<=18 years
0
   0.0%
Between 18 and 65 years
42
  84.0%
>=65 years
8
  16.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
53  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
41
  82.0%
Male
9
  18.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants
50
1.Primary Outcome
Title Pain Score Using a 10-cm Visual Analog Pain Scale (1 = no Pain, 10 = Very Severe Pain)
Hide Description 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).
Time Frame Immediately after injection (Time 0)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiesse® Mixed With Lidocaine Radiesse® Without Lidocaine
Hide Arm/Group Description:
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl)
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: cm
2.8  (1.9) 6.6  (2.2)
2.Primary Outcome
Title Patients With Clinically Significant Reduction in Pain
Hide Description 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).
Time Frame Immediately after injection (Time 0)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radiesse® Mixed With Lidocaine Radiesse® Without Lidocaine
Hide Arm/Group Description:
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl)
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: Participants
45 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Radiesse® Mixed With Lidocaine Radiesse® Without Lidocaine
Hide Arm/Group Description Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl) Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
All-Cause Mortality
Radiesse® Mixed With Lidocaine Radiesse® Without Lidocaine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Radiesse® Mixed With Lidocaine Radiesse® Without Lidocaine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      0/50 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Radiesse® Mixed With Lidocaine Radiesse® Without Lidocaine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   46/50 (92.00%)      45/50 (90.00%)    
Skin and subcutaneous tissue disorders     
Bruising  25/50 (50.00%)  26 25/50 (50.00%)  25
Itching  10/50 (20.00%)  13 12/50 (24.00%)  16
Pain  21/50 (42.00%)  22 23/50 (46.00%)  25
Redness  28/50 (56.00%)  29 30/50 (60.00%)  32
Swelling  44/50 (88.00%)  47 42/50 (84.00%)  44
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Merz Aesthetics, Inc.
Organization: Merz Aesthetics, Inc.
Phone: 650-286-4041
Responsible Party: Merz North America, Inc.
ClinicalTrials.gov Identifier: NCT01012661     History of Changes
Other Study ID Numbers: P0408329
First Submitted: November 10, 2009
First Posted: November 13, 2009
Results First Submitted: December 3, 2009
Results First Posted: January 15, 2010
Last Update Posted: April 26, 2013