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

Contura315 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

315

Conditions

Facial Wrinkles

Interventions

AquamidDEVICE

Subcutaneous injection

RestylaneDEVICE

Injection in dermis

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

White Plains, New York, United States

Outcomes

Primary Outcomes

Wrinkle Assessment Scale

Time frame: Baseline, 3, 6, 9, 12 Months

Adverse device effects

Time frame: continuosly

Secondary Outcomes

Global Aesthetic Improvement Scale

Time frame: Optimal treatment, 3, 6, 9 and 12 Months

Injection site reactions

Time frame: After injection

Adverse events

Time frame: continuosly

Data from ClinicalTrials.gov

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