Juvederm Ultra With Lidocaine Compared With Restylane for the Correction of Nasolabial Folds

This study has been completed.

Sponsor:

Information provided by:

Allergan Medical

ClinicalTrials.gov Identifier:

NCT00850889

First received: February 23, 2009

Last updated: March 23, 2011

Last verified: March 2011

History of Changes

Results First Received: February 24, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Investigator)
Condition:	Nasolabial Folds
Interventions:	Device: Hyaluronic acid gel (24 mg/mL) with 0.3% lidocaine Device: A gel of hyaluronic acid (concentration of 20 mg/mL)

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
Enrollment:32 Study Start Date: November 2008 Study Completion Date: February 2009 Primary Completion Date: November 2008

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
Total Participants	Each participant received Juvederm on one side of the face and Restylane on the other side.

Participant Flow: Overall Study

	Total Participants
STARTED	32
COMPLETED	32
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Total Participants	Each participant received Juvederm on one side of the face and Restylane on the other side.

Baseline Measures

	Total Participants
Number of Participants [units: participants]	32
Age [units: participants]
<=18 years	0
Between 18 and 65 years	30
>=65 years	2
Age [units: years] Mean ± Standard Deviation	51.8 ± 7.82
Gender [units: participants]
Female	31
Male	1
Region of Enrollment [units: participants]
Canada	32

Outcome Measures

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1. Primary:

Procedural Pain Score [ Time Frame: 1 day ]

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2. Secondary:

Comparative Pain [ Time Frame: 1 day ]

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3. Secondary:

Investigator Assessment of Improvement Since Baseline in Nasolabial Fold (NLF) Severity [ Time Frame: Day 0, Day 14 ]

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4. Secondary:

Subject Assessment of Improvement From Baseline in Nasolabial Fold (NLF) Severity [ Time Frame: Day 0, Day 14 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: A 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 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.

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
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Results Point of Contact:

Name/Title: Steven P. James, MD, VP, Global Medical Affairs
Organization: Allergan, Inc.
phone: 714-246-4500
e-mail: james_steven@allergan.com

No publications provided

ClinicalTrials.gov Identifier:	NCT00850889 History of Changes
Other Study ID Numbers:	MA-JULIDO-0801
Study First Received:	February 23, 2009
Results First Received:	February 24, 2011
Last Updated:	March 23, 2011
Health Authority:	Canada: IRB

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