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OpenTrials
Completed

NCT Number: NCT00842062

Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation

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).

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Key information

Conditions

Age range

30 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Aesthetics Research Center

Redwood City, California, 94063, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MyoScience Tissue Remodeling Device

Device

Percutaneous treatment with the MyoScience device

Primary outcomes

  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 outcomes

  1. Incidence of adverse events

    Time frame: Up to 6 months

Sponsors and collaborators

Lead sponsor

Pacira Pharmaceuticals, Inc

Industry

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Feb 12, 2009
Registry last updated
Mar 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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