Status:
COMPLETED
Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation
Lead Sponsor:
Pacira Pharmaceuticals, Inc
Conditions:
Facial Rhytides
Eligibility:
FEMALE
30-70 years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT00842062
Start Date
February 1 2009
End Date
January 1 2012
Last Update
March 24 2015
Active Locations (1)
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1
The Aesthetics Research Center
Redwood City, California, United States, 94063