Efficacy and Safety of Perlane-L in the Correction of Midface Volume Deficit

NCT ID: NCT01565915

Last Updated: 2013-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Facial Volume

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Perlane-L

Perlane-L treatment

Group Type EXPERIMENTAL

Perlane-L

Intervention Type DEVICE

Perlane-L Injection in the midface

Non-Treatment

Non-Treatment Arm

Group Type SHAM_COMPARATOR

Non-treatment

Intervention Type OTHER

Non-treatment Arm

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Perlane-L

Perlane-L Injection in the midface

Intervention Type DEVICE

Non-treatment

Non-treatment Arm

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* History of allergy or hypersensitivity to injectable hyaluronic acid gel or lidocaine.
* Other items as identified in the protocol
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medicis Global Service Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beverly Hills, California, United States

Site Status

San Francisco, California, United States

Site Status

Vista, California, United States

Site Status

Aventura, Florida, United States

Site Status

Coral Gables, Florida, United States

Site Status

Chicago, Illinois, United States

Site Status

Hunt Valley, Maryland, United States

Site Status

Chestnut Hill, Massachusetts, United States

Site Status

Mount Kisco, New York, United States

Site Status

New York, New York, United States

Site Status

Eugene, Oregon, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MA-1400-05

Identifier Type: -

Identifier Source: org_study_id