This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation

This study has been completed.
Information provided by (Responsible Party):
MyoScience, Inc Identifier:
First received: February 10, 2009
Last updated: March 23, 2015
Last verified: March 2015
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).

Condition Intervention Phase
Facial Rhytides Device: MyoScience Tissue Remodeling Device Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation

Further study details as provided by MyoScience, Inc:

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

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Up to 6 months ]

Enrollment: 380
Study Start Date: February 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MyoScience Tissue Remodeling Device Device: MyoScience Tissue Remodeling Device
Percutaneous treatment with the MyoScience device


Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00842062

United States, California
The Aesthetics Research Center
Redwood City, California, United States, 94063
Sponsors and Collaborators
MyoScience, Inc
  More Information

Responsible Party: MyoScience, Inc Identifier: NCT00842062     History of Changes
Other Study ID Numbers: MS-3000
Study First Received: February 10, 2009
Last Updated: March 23, 2015

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes processed this record on August 16, 2017