Safety and Effectiveness of Aquamid as Compared to Restylane for the Aesthetic Treatment of Nasolabial Folds

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-07-31

Brief Summary

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The purpose of this study is to compare the effectiveness of Aquamid and Restylane in aesthetically enhancing nasolabial folds 6 months after treatment and to evaluate the safety of Aquamid through 12 months after treatment.

The study includes an extended follow up to 24 months.

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Detailed Description

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Conditions

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Facial Wrinkles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Aquamid

Group Type EXPERIMENTAL

Aquamid

Intervention Type DEVICE

Subcutaneous injection

2

Restylane

Group Type ACTIVE_COMPARATOR

Restylane

Intervention Type DEVICE

Injection in dermis

Interventions

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Aquamid

Subcutaneous injection

Intervention Type DEVICE

Restylane

Injection in dermis

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* interested on soft tissue augmentation for the nasolabial folds
* moderate to severe nasolabial fold

Exclusion Criteria

* sensitivity to anesthetics
* allergy to hyaluronic acid
* previous treatment with permanent fillers in the treated area
* recent previous aesthetic procedure in the treatment area
* infected skin areas or autoimmune diseases affecting the skin

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes