Facial RhytidesPhase 1/2NCT00842062
Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation
A Phase 1/2 study testing MyoScience Tissue Remodeling Device in people with Facial Rhytides, run by Pacira Pharmaceuticals, Inc at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 30 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Facial Rhytides
- What is being tested?
- MyoScience Tissue Remodeling Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jan 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Aesthetics Research Center
Redwood City, California, 94063
About this study
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).
- Conditions
- Facial Rhytides
- Being tested
- MyoScience Tissue Remodeling Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoScience Tissue Remodeling DeviceDevice
Percutaneous treatment with the MyoScience device
| Study group | Role | What they receive |
|---|---|---|
| MyoScience Tissue Remodeling Device | Experimental | Not described Receives: Device: MyoScience Tissue Remodeling Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigators' and subjects'rating of line severity in the target areas at rest and in animation at each follow-up interval.
Measured: Up to 6 months
Secondary outcomes (1)
Incidence of adverse events
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial RhytidesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842062
- Sponsor's protocol ID
- MS-3000
- Status last verified
- Mar 2015
- First submitted
- 10 Feb 2009
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the MyoScience Tissue Remodeling Device for Facial Rejuvenation
- ClinicalTrials.gov ID
- NCT00842062
- Acronym / sponsor ID
- MS-3000
- Conditions
- Facial Rhytides
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 12 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MyoScience Tissue Remodeling Device | Experimental | Device: MyoScience Tissue Remodeling Device |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyoScience Tissue Remodeling DevicePercutaneous treatment with the MyoScience device | Device | MyoScience Tissue Remodeling Device |
Primary outcome
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
1 secondary outcome
Incidence of adverse events
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MyoScience Tissue Remodeling Device in people with Facial Rhytides, run by Pacira Pharmaceuticals, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.