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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00407914
First Posted: December 5, 2006
Last Update Posted: October 8, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Contura
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
  • Adverse device effects [ Time Frame: continuosly ]

Secondary Outcome Measures:
  • 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: December 4, 2006
First Posted: December 5, 2006
Last Update Posted: October 8, 2009
Last Verified: October 2009

Keywords provided by Contura:
wrinkles
soft tissue filler
Aquamid

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents