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

This study has been completed.
Sponsor:
Information provided by:
Contura
ClinicalTrials.gov Identifier:
NCT00407914
First received: December 4, 2006
Last updated: October 6, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention
Facial Wrinkles
Device: Aquamid
Device: Restylane

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Contura:

Primary Outcome Measures:
  • Wrinkle Assessment Scale [ Time Frame: Baseline, 3, 6, 9, 12 Months ] [ Designated as safety issue: No ]
  • Adverse device effects [ Time Frame: continuosly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Global Aesthetic Improvement Scale [ Time Frame: Optimal treatment, 3, 6, 9 and 12 Months ] [ Designated as safety issue: No ]
  • Injection site reactions [ Time Frame: After injection ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: continuosly ] [ Designated as safety issue: Yes ]

Enrollment: 315
Study Start Date: December 2006
Study Completion Date: July 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Aquamid
Device: Aquamid
Subcutaneous injection
Active Comparator: 2
Restylane
Device: Restylane
Injection in dermis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00407914

Locations
United States, New York
White Plains, New York, United States, 10604
Sponsors and Collaborators
Contura
Investigators
Study Director: Silvia Codony Contura
  More Information

Publications:
Responsible Party: Silvia G Codony, Clinical Research Director, Contura
ClinicalTrials.gov Identifier: NCT00407914     History of Changes
Other Study ID Numbers: CONAQ-US01
Study First Received: December 4, 2006
Last Updated: October 6, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Contura:
wrinkles
soft tissue filler
Aquamid

ClinicalTrials.gov processed this record on April 16, 2014