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Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds

NCT ID: NCT00797459

Last Updated: 2013-09-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-03-31

Brief Summary

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Safety \& tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L) while correcting wrinkles in the area around your nose.

Detailed Description

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A Randomized, Double-Blind Study Comparing Safety and Tolerability of Restylane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds

Conditions

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Nasolabial Folds

Keywords

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Correction of Nasolabial Folds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Restylane and Restylane with Lidocaine

This is a split-face design injecting both Restylane and Restylane-L injectable gels, administered once. Each subject received Restylane on one side of the face, and Restylane-L on the other. Subjects were blinded to which side of their face received Restylane or Restylane-L. The study was randomized and treatments successive.

Group Type EXPERIMENTAL

Restylane and Restylane-L

Intervention Type DEVICE

This is a split face design and each subject received both Restylane and Restylane-L. Treatments were double blind, randomized, and successive.

Interventions

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Restylane and Restylane-L

This is a split face design and each subject received both Restylane and Restylane-L. Treatments were double blind, randomized, and successive.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects seeking augmentation therapy for correction of bilateral NLFs
* Same WSRS score at both NLFs (either both Moderate \[3\] or both Severe \[4\])
* Subjects willing to give written informed consent to participate in the study
* Women of childbearing potential willing to use an acceptable form of birth control during the study period

Exclusion Criteria

* Active or chronic skin disease, inflammation or related conditions, near or on the NLFs
* Subjects who had undergone procedures based on active dermal response e.g., laser or chemical peeling procedures) within 6 months prior to study entry
* Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry
* Permanent implant placed in the NLF area
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Q-Med Scandinavia, Inc.

INDUSTRY

Sponsor Role collaborator

Medicis Global Service Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Bank, MD

Role: PRINCIPAL_INVESTIGATOR

The Center for Dermatology, Cosmetic and Laser Surgery

Fredric Brandt, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Research Institute LLC

Robert Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Maryland Laser Skin and Vein Institute

Ron Staugaard

Role: STUDY_DIRECTOR

Medicis Pharmaceutical

Locations

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Dermatology Research Institute LLC

Coral Gables, Florida, United States

Site Status

Maryland Laser Skin and Vein Institute

Hunt Valley, Maryland, United States

Site Status

The Center for Dermatology, Cosmetic and Laser Surgery

Mount Kisco, New York, United States

Site Status

Countries

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United States

Other Identifiers

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MA-1100-001

Identifier Type: -

Identifier Source: org_study_id