Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation

A prospective, non-randomized study to evaluate the performance of the MyoScience Tissue Remodeling Device for the treatment of glabellar lines (frown lines), lateral orbital lines (crow's feet), and frontalis lines (horizontal forehead lines).

Study Overview

• Status: Completed
• Conditions: Facial Rhytides
• Intervention / Treatment: Device: MyoScience Tissue Remodeling Device

• Study Type: Interventional
• Enrollment (Actual): 380
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • The Aesthetics Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• The subject must be a female 30 to 70 years of age.
• The subject must have a clinical examination prior to treatment including assessment of hyperdynamic line severity.
• The subject must have a wrinkle rating of at least "1" at rest in one or more of the following treatment areas (glabellar, lateral orbital, or frontalis).
• The subject must have signed an informed consent form.
• The subject should not have undergone any other facial cosmetic procedures at or above the level of the cheekbones within the past 6 months.
• The subject should not be participating in any other facial cosmetic research study.

Exclusion Criteria:

• The subject is on a regular regimen of prescribed or over-the-counter anticoagulants.
• The subject has an infection or skin problem at the injection site.
• The subject has a history of facial nerve palsy.
• The subject has marked facial asymmetry.
• The subject has ptosis.
• The subject has excessive dermatochalasis.
• The subject has deep dermal scarring.
• The subject has thick sebaceous skin.
• The investigator is unable to substantially lessen facial lines by physical separation.
• The subject has a history of neuromuscular disorder.
• The subject has undergone prior surgery that alters the subcutaneous anatomy of the areas being treated.
• Subjects with laxity of the canthal tendon and/or with lower lid retraction, and subjects who recruit their zygomaticus major muscle to animate their crow's feet.
• The subject has any physical or psychiatric condition that in the investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MyoScience Tissue Remodeling Device	Device: MyoScience Tissue Remodeling Device; Percutaneous treatment with the MyoScience device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Investigators' and subjects'rating of line severity in the target areas at rest and in animation at each follow-up interval.	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	Up to 6 months

Collaborators and Investigators

• Sponsor: Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: February 10, 2009
• First Submitted That Met QC Criteria: February 11, 2009
• First Posted (Estimate): February 12, 2009

Study Record Updates

• Last Update Posted (Estimate): March 24, 2015
• Last Update Submitted That Met QC Criteria: March 23, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies
• Other Study ID Numbers: MS-3000