Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

MyoScience, Inc

ClinicalTrials.gov Identifier:

NCT00842062

First received: February 10, 2009

Last updated: February 10, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 10, 2009
Last Updated Date	February 10, 2012
Start Date ^ICMJE	February 2009
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 25, 2009)	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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00842062 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 25, 2009)	Incidence of adverse events [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation
Official Title ^ICMJE	Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation
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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Facial Rhytides
Intervention ^ICMJE	Device: MyoScience Tissue Remodeling Device Percutaneous treatment with the MyoScience device
Study Arm (s)	Experimental: MyoScience Tissue Remodeling Device Intervention: Device: MyoScience Tissue Remodeling Device
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	384
Completion Date	January 2012
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages	30 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00842062
Other Study ID Numbers ^ICMJE	MS-3000
Has Data Monitoring Committee	No
Responsible Party	MyoScience, Inc
Study Sponsor ^ICMJE	MyoScience, Inc
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	MyoScience, Inc
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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