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

Contura

Status: Completed

Conditions: Facial Wrinkles

Treatments: Device: Aquamid; Device: Restylane

Study type: Interventional

Funder types: Industry

Identifiers

NCT00407914

CONAQ-US01

Details and patient eligibility

About

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.

Enrollment: 315 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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315 participants in 2 patient groups

1

Experimental group

Description:

Aquamid

Treatment:

Device: Aquamid

2

Active Comparator group

Description:

Restylane

Treatment:

Device: Restylane