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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:
Information provided by:
Contura
ClinicalTrials.gov Identifier:
NCT00407914
First received: December 4, 2006
Last updated: October 6, 2009
Last verified: October 2009
History of Changes

December 4, 2006
October 6, 2009
December 2006
August 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • Wrinkle Assessment Scale
  • Adverse device effects
Complete list of historical versions of study NCT00407914 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Global Aesthetic Improvement Scale
  • Injection site reactions
  • Adverse events
Not Provided
Not Provided
 
Safety and Effectiveness of Aquamid as Compared to Restylane for the Aesthetic Treatment of Nasolabial Folds
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

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Facial Wrinkles
  • Device: Aquamid
    Subcutaneous injection
  • Device: Restylane
    Injection in dermis
  • Experimental: 1
    Aquamid
    Intervention: Device: Aquamid
  • Active Comparator: 2
    Restylane
    Intervention: Device: Restylane
von Buelow S, von Heimburg D, Pallua N. Efficacy and safety of polyacrylamide hydrogel for facial soft-tissue augmentation. Plast Reconstr Surg. 2005 Sep 15;116(4):1137-46; discussion 1147-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
315
July 2009
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00407914
CONAQ-US01
Not Provided
Silvia G Codony, Clinical Research Director, Contura
Contura
Not Provided
Study Director: Silvia Codony Contura
Contura
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP