NCT00877279

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
Last Updated

November 15, 2013

Status Verified

October 1, 2013

Enrollment Period

4 months

First QC Date

April 3, 2009

Last Update Submit

October 23, 2013

Conditions

Facial Wrinkles

Keywords

Facial wrinklesNasolabial folds

Outcome Measures

Primary Outcomes (1)

  • The severity of the facial wrinkle

    2 weeks and 4 weeks

Secondary Outcomes (1)

  • Investigator and subject assessments

    2 weeks and 4 weeks

Study Arms (2)

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

CosmoDerm1DEVICE

CosmoDerm1 is a single use syringe, injected into the mid dermal layer.

CosmoDerm1
Belotero SoftDEVICE

Dermal Filler

Belotero® Soft

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must have bilateral facial wrinkles, such as nasolabial folds

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Skin Care & Laser Physicians of Beverly Hills

Los Angeles, California, 90069, United States

Location

Maas Clinic

San Francisco, California, 94115, United States

Location

Savin Dermatology Center

New Haven, Connecticut, 06511, United States

Location

William Coleman, III, MD

Metairie, Louisiana, 70006, United States

Location

Dermatology Surgery and Laser Center

White Plains, New York, 10604, United States

Location

Study Officials

  • Rhoda Narins, MD

    Dermatology Surgery and Laser Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2009

First Posted

April 7, 2009

Study Start

November 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

November 15, 2013

Record last verified: 2013-10

Locations

US(5)