Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation

NCT ID: NCT00842062

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2012-01-31

Brief Summary

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).

Conditions

Facial Rhytides

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MyoScience Tissue Remodeling Device

Group Type: EXPERIMENTAL

MyoScience Tissue Remodeling Device

Intervention Type: DEVICE

Percutaneous treatment with the MyoScience device

Interventions

MyoScience Tissue Remodeling Device

Percutaneous treatment with the MyoScience device

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Aesthetics Research Center

Redwood City, California, United States

Countries

United States

Other Identifiers

MS-3000

Identifier Type: -

Identifier Source: org_study_id