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

October 6, 2009 updated by: Contura

A Double-Masked, Randomized, Multi-Center, 2-Arm Parallel Study Comparing the Safety and Effectiveness of Aquamid and Restylane for the Aesthetic Treatment of Nasolabial Folds

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

315

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • White Plains, New York, United States, 10604

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Aquamid
Device: Aquamid
Subcutaneous injection
Active Comparator: 2
Restylane
Device: Restylane
Injection in dermis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Wrinkle Assessment Scale
Time Frame: Baseline, 3, 6, 9, 12 Months
Baseline, 3, 6, 9, 12 Months
Adverse device effects
Time Frame: continuosly
continuosly

Secondary Outcome Measures

Outcome Measure
Time Frame
Global Aesthetic Improvement Scale
Time Frame: Optimal treatment, 3, 6, 9 and 12 Months
Optimal treatment, 3, 6, 9 and 12 Months
Injection site reactions
Time Frame: After injection
After injection
Adverse events
Time Frame: continuosly
continuosly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Contura

Investigators

  • Study Director: Silvia Codony, Contura

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

December 4, 2006

First Submitted That Met QC Criteria

December 4, 2006

First Posted (Estimate)

December 5, 2006

Study Record Updates

Last Update Posted (Estimate)

October 8, 2009

Last Update Submitted That Met QC Criteria

October 6, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CONAQ-US01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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