Multicenter Study of the Safety and Efficacy of Dermal Fi... | NCT00877279

Studies
Multicenter Study of the Safety and Efficacy of Dermal Filler, Belotero® Soft

NCT00877279

Sponsor

Merz North America, Inc.

Status

Completed

Last Update Posted

Nov 15, 2013Estimated

Enrollment

64Actual

Phase

Phase 3

Conditions

Facial Wrinkles

Interventions

CosmoDerm1
Belotero Soft

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 2013

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

Nov 2007

Primary Completion Date

Mar 2008Actual

Completion Date

Mar 2008Actual

First Submitted Date

Apr 3, 2009

First Submission Date that Met QC Criteria

Apr 6, 2009

First Posted Date

Apr 7, 2009Estimated

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

Oct 12, 2011

Certification/Extension First Submitted that Passed QC Review

Oct 12, 2011

Certification/Extension First Posted Date

Oct 21, 2011Estimated

Last Update Submitted Date

Oct 23, 2013

Last Update Posted Date

Nov 15, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is to determine the safety and effectiveness of Belotero® Soft compared to active comparator in the correction of mild facial wrinkles, such as nasolabial folds.

Detailed Description

The purpose of the study is to see if Belotero® Soft is safe and effective for correction of mild facial wrinkles, such as nasolabial folds. The second objective of the study is to see if Belotero® Soft works better than the active comparator. Subjects will receive Belotero® Soft injection to one side of the face and the active comparator to the other side of the face.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Belotero® Soft	Experimental	Comparator will be given into the opposite side of the face that Belotero® Soft was administered for facial wrinkles, such as nasolabial folds.	Device: Belotero Soft
CosmoDerm1	Active Comparator		Device: CosmoDerm1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CosmoDerm1	Device	CosmoDerm1 is a single use syringe, injected into the mid dermal layer.	CosmoDerm1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The severity of the facial wrinkle		2 weeks and 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Investigator and subject assessments		2 weeks and 4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects must have bilateral facial wrinkles, such as nasolabial folds

Exclusion Criteria:

Other nasolabial fold correction within 6 months prior to study entry.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rhoda Narins, MD	Dermatology Surgery and Laser Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Skin Care & Laser Physicians of Beverly Hills		Los Angeles	California	90069	United States
Maas Clinic