Evaluate Efficacy, Safety & Subject Satisfaction of Pain Management With Pliaglis® Cream for Dermal Filler Injections

This study has been terminated.
(Sponsor decision)
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT00716443
First received: July 14, 2008
Last updated: September 21, 2012
Last verified: September 2012
Results First Received: September 25, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Nasolabial Folds
Interventions: Drug: tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream)
Drug: benzocaine 20% / lidocaine 6% / tetracaine 4% ointment

  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
Dates of recruitment period: First subject was enrolled on July 30, 2008 and the last subject was enrolled on September 8, 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The wash-out period prior to baseline was 24 hrs for analgesic medication; 14 days for aspirin (ASA), non-steroidal anti-inflammatory drugs (NSAIDs), anticoagulants, St. John's Wort or doses of Vitamin E above the recommended daily allowance; 14 days for sunburn/tanning bed exposure; 12 months for filler injections into the nasolabial folds.

Reporting Groups
  Description
Pliaglis® Cream and Compounded Topical Anesthetic Ointment Apply Pliaglis® Cream on one side of the face and compounded topical anesthetic ointment on the other side of the face; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and compounded topical anesthetic ointment was used on the other side of the face prior to injection of Restylane® into the nasolabial folds.

Participant Flow:   Overall Study
    Pliaglis® Cream and Compounded Topical Anesthetic Ointment  
STARTED     51  
COMPLETED     51  
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
Pliaglis® Cream and Compounded Topical Anesthetic Ointment Apply Pliaglis® Cream on one side of the face and compounded topical anesthetic ointment on the other side of the face; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and compounded topical anesthetic ointment was used on the other side of the face prior to injection of Restylane® into the nasolabial folds.

Baseline Measures
    Pliaglis® Cream and Compounded Topical Anesthetic Ointment  
Number of Participants  
[units: participants]
  51  
Age  
[units: years]
Mean ± Standard Deviation
  47.8  ± 8.34  
Gender  
[units: participants]
 
Female     50  
Male     1  



  Outcome Measures
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1.  Primary:   Subject's Pain Evaluation by Visual Analog Scale (VAS)Upon First Needlestick, Immediately After Injection, One Hour After Injection and Three Hours After Injection of Restylane® Into the Nasolabial Folds   [ Time Frame: upon first needlestick, immediately after injection, one hour after injection and three hours after injection of Restylane® into the nasolabial folds ]

2.  Secondary:   Number of Participants Who Answered the Question "What Level of Pain Did You Experience When You Were Injected?" Three Hours After Injection of Restylane® Into the Nasolabial Folds   [ Time Frame: three hours after injection of Restylane® into the nasolabial folds ]

3.  Secondary:   Number of Participants Who Answered the Question "If You Experienced Pain, Was it What You Expected From the Injection Procedure?" Three Hours After Injection of Restylane® Into the Nasolabial Folds   [ Time Frame: three hours after injection of Restylane® into the nasolabial folds ]

4.  Secondary:   Number of Participants Who Answered the Question "If it Was Different Than What You Expected, Was it?" Three Hours After Injection of Restylane® Into the Nasolabial Folds   [ Time Frame: three hours after injection of Restylane® into the nasolabial folds ]

5.  Secondary:   Number of Participants Who Answered the Question "Still Speaking to the Topical Anesthetic You Had on the Right/Left Side of Your Face, Would You Recommend it to Your Friend or Family Member?" 3 Hours After Injection of Restylane® Into Nasolabial Folds   [ Time Frame: three hours after injection of Restylane® into the nasolabial folds ]

6.  Secondary:   Number of Participants in Each Category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment Scale Upon First Needle Stick of Injection of Restylane® Into the Nasolabial Folds   [ Time Frame: Upon first needle stick of injection of Restylane® into the nasolabial folds ]

7.  Secondary:   Number of Participants in Each Category of the Investigator Evaluation of the Subject's Post Procedure Pain Assessment Scale Immediately After Injection of Restylane® Into the Nasolabial Folds   [ Time Frame: immediately after injection of Restylane® into the nasolabial folds ]

8.  Secondary:   Number of Participants in Each Category of the Investigator's Evaluation of Subject's Pain Scale One Hour After Injection of Restylane® Into the Nasolabial Folds   [ Time Frame: one hour after injection of Restylane® into the nasolabial folds ]

9.  Secondary:   Number of Participants in Each Category of the Investigator's Evaluation of Subject's Pain Scale Three Hours After Injection of Restylane® Into the Nasolabial Folds   [ Time Frame: three hours after injection of Restylane® into the nasolabial folds ]

10.  Secondary:   Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Upon First Needle Stick of Injection of Restylane® Into the Nasolabial Folds   [ Time Frame: upon first needle stick of injection of Restylane® into the nasolabial folds ]

11.  Secondary:   Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Immediately After Injection of Restylane® Into the Nasolabial Folds   [ Time Frame: immediately after injection of Restylane® into the nasolabial folds ]

12.  Secondary:   Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale One Hour After Injection of Restylane® Into the Nasolabial Folds   [ Time Frame: one hour after injection of Restylane® into the nasolabial folds ]

13.  Secondary:   Number of Participants in Each Category of the Blinded Evaluator's Evaluation of Subject's Pain Scale Three Hours After Injection of Restylane® Into the Nasolabial Folds   [ Time Frame: three hours after injection of Restylane® into the nasolabial folds ]

14.  Secondary:   Number of Participants With Yes/no Answers to Question to Investigator "Did the Topical Anesthetics Provide Adequate Anesthesia for the Injections of Restylane® Into the Nasolabial Folds Procedure?" Day of Injection of Restylane® Into Nasolabial Folds   [ Time Frame: Day of injection of Restylane® into the nasolabial folds ]

15.  Secondary:   Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Days After Injection of Restylane® Into the Nasolabial Folds   [ Time Frame: Baseline to two days after injection of Restylane® into the nasolabial folds ]


  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: Ron W. Gottschalk, MD / Medical Director
Organization: Galderma Laboratories, L.P.
phone: 817-961-5358
e-mail: ron.gottschalk@galderma.com


No publications provided


Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00716443     History of Changes
Other Study ID Numbers: US10098
Study First Received: July 14, 2008
Results First Received: September 25, 2009
Last Updated: September 21, 2012
Health Authority: United States: Institutional Review Board