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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01012661
First Posted: November 13, 2009
Last Update Posted: April 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merz North America, Inc.
Results First Submitted: December 3, 2009  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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).

Participant Flow:   Overall Study
    Radiesse® Mixed With Lidocaine & Radiesse® Without Lidocaine
STARTED   50 
COMPLETED   50 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Radiesse® Mixed With Lidocaine and 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)

Baseline Measures
   Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine 
Overall Participants Analyzed 
[Units: Participants]
 50 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   42 
>=65 years   8 
Age 
[Units: Years]
Mean (Standard Deviation)
 53  (10.1) 
Gender 
[Units: Participants]
 
Female   41 
Male   9 
Region of Enrollment 
[Units: Participants]
 
United States   50 


  Outcome Measures
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1.  Primary:   Pain Score Using a 10-cm Visual Analog Pain Scale (1 = no Pain, 10 = Very Severe Pain)   [ Time Frame: Immediately after injection (Time 0) ]

2.  Primary:   Patients With Clinically Significant Reduction in Pain   [ Time Frame: Immediately after injection (Time 0) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Merz Aesthetics, Inc.
Organization: Merz Aesthetics, Inc.
phone: 650-286-4041
e-mail: clinicaltrials@merzaesthetics.com


Publications of Results:

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