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

Facial Wrinkles Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00407914
• Other study ID #: CONAQ-US01
• Status: Completed
• Phase: N/A
• First received: December 4, 2006
• Last updated: October 6, 2009
• Start date: December 2006
• Est. completion date: July 2009

Study information

• Verified date: October 2009
• Source: Contura
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: July 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Facial Wrinkles

Intervention

Device:
• Aquamid
Subcutaneous injection
• Restylane
Injection in dermis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Contura

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wrinkle Assessment Scale		Baseline, 3, 6, 9, 12 Months	No
Primary	Adverse device effects		continuosly	Yes
Secondary	Global Aesthetic Improvement Scale		Optimal treatment, 3, 6, 9 and 12 Months	No
Secondary	Injection site reactions		After injection	Yes
Secondary	Adverse events		continuosly	Yes