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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014