This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

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

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
Device: Aquamid
Subcutaneous injection
Active Comparator: 2
Device: Restylane
Injection in dermis


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier: NCT00407914

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

Responsible Party: Silvia G Codony, Clinical Research Director, Contura Identifier: NCT00407914     History of Changes
Other Study ID Numbers: CONAQ-US01
Study First Received: December 4, 2006
Last Updated: October 6, 2009

Keywords provided by Contura:
soft tissue filler

Additional relevant MeSH terms:
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents processed this record on September 21, 2017