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CompletedNCT00842062Updated Mar 24, 2015

Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation

A Phase 1/2 interventional study of MyoScience Tissue Remodeling Device in Facial Rhytides, sponsored by Pacira Pharmaceuticals, Inc. Completed at 1 site in United States. Open to female participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-24.

Sponsored by Pacira Pharmaceuticals, Inc · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
380
Allocation
Not applicable
Ages
30 Years to 70 Years
Sex
Female
01

Study 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).

02

Conditions studied

  • Facial Rhytides

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03

In context

Facies

217 studies on the registry are indexed under Facies; 35 are open to participants now.

This study's enrollment of 380 is above the median of 40 across 161 interventional studies indexed under Facies.

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Lead sponsor

Pacira Pharmaceuticals, Inc is the lead sponsor of 100 studies on the registry; 3 are open to participants now.

Of its 26 completed or terminated interventional studies of FDA-regulated products, 17 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
380 participants (actual)

Study arms

  • Experimental
    MyoScience Tissue Remodeling Device

    Device: MyoScience Tissue Remodeling Device

Interventions

  • DeviceMyoScience Tissue Remodeling Device

    Percutaneous treatment with the MyoScience device

06

What researchers measure

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

07

Study locations

1 site
  • The Aesthetics Research Center
    Redwood City, California 94063, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00842062
Lead sponsor
Pacira Pharmaceuticals, Inc
Responsible party
Sponsor
First posted
Feb 12, 2009
Start date
Feb 2009
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Mar 24, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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