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

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. Identifier: NCT00407914
Recruitment Status : Completed
First Posted : December 5, 2006
Last Update Posted : October 8, 2009
Information provided by:

Brief Summary:

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 or disease Intervention/treatment Phase
Facial Wrinkles Device: Aquamid Device: Restylane Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
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
Study Start Date : December 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: 1
Device: Aquamid
Subcutaneous injection

Active Comparator: 2
Device: Restylane
Injection in dermis

Primary Outcome Measures :
  1. Wrinkle Assessment Scale [ Time Frame: Baseline, 3, 6, 9, 12 Months ]
  2. Adverse device effects [ Time Frame: continuosly ]

Secondary Outcome Measures :
  1. Global Aesthetic Improvement Scale [ Time Frame: Optimal treatment, 3, 6, 9 and 12 Months ]
  2. Injection site reactions [ Time Frame: After injection ]
  3. Adverse events [ Time Frame: continuosly ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00407914

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

Responsible Party: Silvia G Codony, Clinical Research Director, Contura Identifier: NCT00407914     History of Changes
Other Study ID Numbers: CONAQ-US01
First Posted: December 5, 2006    Key Record Dates
Last Update Posted: October 8, 2009
Last Verified: October 2009

Keywords provided by Contura:
soft tissue filler

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