NCT01565915

Brief Summary

The purpose of this study is to determine if Perlane-L is safe in increasing cheek volume.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
221

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

11 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 29, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 21, 2013

Status Verified

August 1, 2013

Enrollment Period

1.8 years

First QC Date

March 12, 2012

Last Update Submit

August 20, 2013

Conditions

Facial Volume

Outcome Measures

Primary Outcomes (1)

  • Facial fullness using midface scale

    Change in facial fullness using midface scale.

    Week 8

Secondary Outcomes (3)

  • Facial fullness using the midface scale

    Up to 12-months post treatment

  • Subject satisfaction using the GAIS

    Up to 12-months post treatment

  • Aesthetic improvement

    Up to 12-months post treatment

Study Arms (2)

Perlane-L

EXPERIMENTAL

Perlane-L treatment

Device: Perlane-L

Non-Treatment

SHAM COMPARATOR

Non-Treatment Arm

Other: Non-treatment

Interventions

Perlane-LDEVICE

Perlane-L Injection in the midface

Perlane-L
Non-treatmentOTHER

Non-treatment Arm

Non-Treatment

Eligibility Criteria

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

You may qualify if:

  • Loss of Fullness in Midface Area
  • Other items as identified in the protocol

You may not qualify if:

  • History of allergy or hypersensitivity to injectable hyaluronic acid gel or lidocaine.
  • Other items as identified in the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Beverly Hills, California, United States

Location

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

Vista, California, United States

Location

Unknown Facility

Aventura, Florida, United States

Location

Unknown Facility

Coral Gables, Florida, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Hunt Valley, Maryland, United States

Location

Unknown Facility

Chestnut Hill, Massachusetts, United States

Location

Unknown Facility

Mount Kisco, New York, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Eugene, Oregon, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2012

First Posted

March 29, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

August 21, 2013

Record last verified: 2013-08

Locations

US(11)