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Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation

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ClinicalTrials.gov Identifier: NCT00842062
Recruitment Status : Completed
First Posted : February 12, 2009
Last Update Posted : March 24, 2015
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Facial Rhytides Device: MyoScience Tissue Remodeling Device Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation
Study Start Date : February 2009
Primary Completion Date : January 2012
Study Completion Date : January 2012
Arms and Interventions

Arm Intervention/treatment
Experimental: MyoScience Tissue Remodeling Device Device: MyoScience Tissue Remodeling Device
Percutaneous treatment with the MyoScience device

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Incidence of adverse events [ Time Frame: Up to 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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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

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

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 Posted: February 12, 2009    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes