Safety and Effectiveness of Aquamid as Compared to Restyl... | NCT00407914

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

NCT00407914

Sponsor

Contura

Status

Completed

Last Update Posted

Oct 8, 2009Estimated

Enrollment

315Actual

Phase

Not Applicable

Conditions

Facial Wrinkles

Interventions

Aquamid
Restylane

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Aug 2008Actual

Completion Date

Jul 2009Actual

First Submitted Date

Dec 4, 2006

First Submission Date that Met QC Criteria

Dec 4, 2006

First Posted Date

Dec 5, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jul 1, 2009

Certification/Extension First Submitted that Passed QC Review

Jul 1, 2009

Certification/Extension First Posted Date

Oct 8, 2009Estimated

Last Update Submitted Date

Oct 6, 2009

Last Update Posted Date

Oct 8, 2009Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

315Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Aquamid	Device: Aquamid
2	Active Comparator	Restylane	Device: Restylane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aquamid	Device	Subcutaneous injection	1
Restylane

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Wrinkle Assessment Scale		Baseline, 3, 6, 9, 12 Months
Adverse device effects		continuosly

Secondary Outcomes

Measure	Description	Time Frame
Global Aesthetic Improvement Scale		Optimal treatment, 3, 6, 9 and 12 Months
Injection site reactions		After injection
Adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Silvia Codony	Contura	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		White Plains	New York	10604	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16163108	Background	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. doi: 10.1097/01.prs.0000179349.14392.a4.