A Study of Treatment Preference During Cheek Contouring Comparing Restylane® SubQ With and Without the Addition of Lidocaine Hydrochloride

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Q-Med AB
ClinicalTrials.gov Identifier:
NCT01431755
First received: September 6, 2011
Last updated: April 23, 2014
Last verified: April 2014
Results First Received: October 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject)
Condition: Facial Tissue Augmentation
Interventions: Device: Restylane SubQ
Device: Restylane SubQ Lidocaine

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First subject enrolled: September 10, 2011 Last subject visit: October 19, 2012

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study has split-face design. Each subject is randomized to treatment with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek.

Reporting Groups
  Description
Restylane SubQ/Restylane SubQ Lidocaine The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.

Participant Flow:   Overall Study
    Restylane SubQ/Restylane SubQ Lidocaine  
STARTED     54  
COMPLETED     49  
NOT COMPLETED     5  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Restylane SubQ/Restylane SubQ Lidocaine The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended

Baseline Measures
    Restylane SubQ/Restylane SubQ Lidocaine  
Number of Participants  
[units: participants]
  54  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     45  
>=65 years     9  
Age  
[units: years]
Mean ± Standard Deviation
  53  ± 13.1  
Gender  
[units: participants]
 
Female     51  
Male     3  
Region of Enrollment  
[units: participants]
 
Sweden     54  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Subjects Who Assessed Treatment With Restylane SubQ Lidocaine as Least Painful.   [ Time Frame: When injection of both cheeks were completed ]

2.  Secondary:   Subject Pain Assessment by Visual Analogue Scale (VAS) 15 and 120 Minutes After Treatment.   [ Time Frame: 15 and 120 minutes ]

3.  Secondary:   Percentage of Improved Subjects at 2 Weeks After Treatment as Assessed by Use of Global Esthetic Improvement Scale (GEIS)   [ Time Frame: 2 weeks ]

4.  Secondary:   Percentage of Subjects With at Least One Step Improvement on Medicis Midface Volume Scale (MMVS) at 2 Weeks   [ Time Frame: 2 weeks ]

5.  Secondary:   Number of Subjects Reporting at Least 1 Diary Complaint Related to the Cheek Treated With Restylane SubQ and Restylane SubQ Lidocaine Respectively After Initial Treatment.   [ Time Frame: 14 days ]

6.  Secondary:   Number of Subjects Reporting Adverse Event   [ Time Frame: Up to 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: Head of Medical Affairs
Organization: Q-Med AB
phone: +46 (0) 18 474 90 00
e-mail: reception.SEUPP@galderma.com


No publications provided


Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT01431755     History of Changes
Other Study ID Numbers: 31GE1101
Study First Received: September 6, 2011
Results First Received: October 16, 2013
Last Updated: April 23, 2014
Health Authority: Sweden: Regional Ethical Review Board