We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00842062
First Posted: February 12, 2009
Last Update Posted: March 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MyoScience, Inc
  Purpose
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: None (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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842062


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

Responsible Party: MyoScience, Inc
ClinicalTrials.gov Identifier: NCT00842062     History of Changes
Other Study ID Numbers: MS-3000
First Submitted: February 10, 2009
First Posted: February 12, 2009
Last Update Posted: March 24, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Facies
Disease Attributes
Pathologic Processes