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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-10-31

Brief Summary

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The objectives of this study are to evaluate the pain-relieving effect and safety of adding lidocaine hydrochloride to Restylane SubQ and to evaluate the esthetic improvement obtained. The study products will be administered in the cheek.

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Detailed Description

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The Restylane SubQ gel is intended to be used for facial tissue augmentation. The lidocaine content is designed to reduce the subject's pain during treatment. The objectives of this split-face designed study are to evaluate the pain-relieving effect and safety of adding lidocaine hydrochloride to Restylane SubQ and to evaluate the esthetic improvement obtained with the dermal filler using the global esthetic improvement scale (GEIS).

Conditions

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Facial Tissue Augmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Restylane SubQ

Group Type OTHER

Restylane SubQ

Intervention Type DEVICE

Treatment with up to 2 ml of the product

Restylane SubQ Lidocaine

Group Type OTHER

Restylane SubQ Lidocaine

Intervention Type DEVICE

Treatment with up to 2 ml of the product

Interventions

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Restylane SubQ

Treatment with up to 2 ml of the product

Intervention Type DEVICE

Restylane SubQ Lidocaine

Treatment with up to 2 ml of the product

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older.
* Intent to undergo contouring of both cheeks with 1.5 to 2 ml Restylane SubQ per cheek.
* Sufficient symmetry of the face in order to ensure similar volume to be injected, similar injection technique and time for injection.
* Signed informed consent.

Exclusion Criteria

* Surgery in the midface including aesthetic facial surgical therapy, sinus surgery or dental root surgery within the past 12 months.
* Chronic infection in head and neck region.
* Ongoing infections in mouth.
* Tendency for edema, puffiness or swelling over the zygomatic prominence.
* Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or on the area to be treated.
* Previous hypersensitivity to hyaluronic acid or local anesthetics.
* Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation within 10 days prior to treatment, or a history of bleeding disorders.
* Cancerous or pre-cancerous lesions in the area to be treated.
* Previous tissue augmenting therapy in the area to be treated with non-permanent filler, laser treatment, or chemical peeling during the last 6 months.
* Permanent implant placed in the area to be treated.
* Reduced sensibility in the facial region e.g. due to trauma, facial pareses, previous tissue augmenting therapy, aesthetic facial surgical therapy, laser treatment, or peeling.
* Pregnancy or breast feeding.
* Participation in any other clinical study within 30 days prior to inclusion.
* Other condition preventing the subject to entering the study in the Investigator's opinion e.g. subjects not likely to avoid other facial cosmetic treatments below the level of the upper orbital rim, subjects anticipated to be unreliable or incapable of understanding the VAS assessment, insufficient tissue support or cover of the treatment area.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes