A Study to Compare the Safety and Effectiveness of a Non-FDA Approved Device Dermal Gel Extra (DGE) and an FDA Approved Device for the Correction of Nasolabial Folds (NLFs)

This study has been completed.
Sponsor:
Collaborator:
Mentor Worldwide, LLC
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00444626
First received: March 7, 2007
Last updated: April 7, 2015
Last verified: April 2015
Results First Received: April 7, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Facial Wrinkles at the Nasolabial Folds
Interventions: Device: Dermal Gel Extra (DGE)
Device: Restylane
Drug: EMLA Cream

  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
166 subjects screened, 26 subjects were never randomized.

Reporting Groups
  Description
Combined Arm Participants received DGE in one nasolabial fold (NLF) on one side of their face and Restylane in one NLF on the other side of their face (blinded, split-face study design) in the Initial Treatment. For participants who continued into the Repeat Treatment Period, they received DGE in both NLFs as an open-label treatment.

Participant Flow for 2 periods

Period 1:   Initial Treatment Period
    Combined Arm  
STARTED     140  
COMPLETED     128  
NOT COMPLETED     12  
Withdrawal by Subject                 2  
Adverse Event                 1  
Lost to Follow-up                 9  

Period 2:   Repeat Treatment Period
    Combined Arm  
STARTED     105 [1]
COMPLETED     105  
NOT COMPLETED     0  
[1] 23 subjects withdrew after completing the Initial Treatment and did not enter the Repeat Treatment



  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.
No text entered.

Reporting Groups
  Description
Combined Arms Participants received DGE in one nasolabial fold (NLF) on one side of their face and Restylane in one NLF on the other side of their face (blinded, split-face study design) in the Initial Treatment. For participants who continued into the Repeat Treatment Period, they received DGE in both NLFs as an open-label treatment.

Baseline Measures
    Combined Arms  
Number of Participants  
[units: participants]
  140  
Age  
[units: years]
Mean (Standard Deviation)
  52.7  (9.3)  
Gender  
[units: participants]
 
Female     135  
Male     5  
Race/Ethnicity, Customized [1]
[units: participants]
 
American Indian or Alaskan Native     9  
Asian     1  
Black or African American     24  
Native Hawaiian or Other Pacific Islander     2  
White     100  
Other     5  
Not Available     3  
[1] Multiple responses were possible for race as the screening visit CRF stated “check all that apply”.



  Outcome Measures
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1.  Primary:   Change From Baseline in the Blinded Evaluator’s Assessment of Nasolabial Fold (NLF) Wrinkle Severity at Week 24   [ Time Frame: Week 24 ]

2.  Secondary:   Participant’s Pain Assessment During the Initial Treatment Measured on a Visual Analog Scale (VAS)   [ Time Frame: Day 1 ]

3.  Secondary:   Change From Baseline in the Blinded Evaluator’s Assessment of Nasolabial Folds (NLF) Wrinkle Severity at Week 36   [ Time Frame: Week 36 ]

4.  Secondary:   Number of Participants With at Least a 1 Point Improvement From Baseline in the Blinded Evaluator’s Assessment of Wrinkle Severity at Week 24   [ Time Frame: Week 24 ]

5.  Secondary:   Participant Product Preference at Week 24   [ Time Frame: Week 24 ]

6.  Secondary:   Participant Product Preference at Week 36   [ Time Frame: Week 36 ]

7.  Secondary:   Number of Participants With Treatment-Emergent Adverse Events During the Initial Treatment Period   [ Time Frame: Weeks 1-36 ]

8.  Secondary:   Number of Participants With Treatment-Emergent Adverse Events During the Repeat Treatment Period   [ Time Frame: weeks 36 up to 47 weeks ]


  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: Genzyme Medical Information (MedInfo)
Organization: Genzyme
e-mail: medinfo@genzyme.com


No publications provided


Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00444626     History of Changes
Other Study ID Numbers: DGE00105
Study First Received: March 7, 2007
Results First Received: April 7, 2015
Last Updated: April 7, 2015
Health Authority: United States: Food and Drug Administration