Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation

NCT00842062 | Completed Phase 1

• 1 other identifier: MS-3000
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of adverse events

  Up to 6 months

Study Arms (1)

MyoScience Tissue Remodeling Device

EXPERIMENTAL

Device: MyoScience Tissue Remodeling Device

Interventions

MyoScience Tissue Remodeling Device DEVICE

Percutaneous treatment with the MyoScience device

MyoScience Tissue Remodeling Device

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (1)

The Aesthetics Research Center

Redwood City, California, 94063, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2009
• First Posted: February 12, 2009
• Study Start: February 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

US (1)