Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation

Facial Rhytides Clinical Trial

Official title:

Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00842062
• Other study ID #: MS-3000
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 10, 2009
• Last updated: March 23, 2015
• Start date: February 2009
• Est. completion date: January 2012

Study information

• Verified date: March 2015
• Source: MyoScience, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Facial Rhytides
• Facies

Intervention

Device:
• MyoScience Tissue Remodeling Device
Percutaneous treatment with the MyoScience device

Locations

Country	Name	City	State
United States	The Aesthetics Research Center	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
MyoScience, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of adverse events		Up to 6 months	Yes