Facial WrinklesPhase 2/3NCT01167140
Cryo-Touch II for the Treatment of Wrinkles
A Phase 2/3 study testing Cryo-Touch II in people with Facial Wrinkles, run by Pacira Pharmaceuticals, Inc at 1 site in United States.
Trial summary
This is a prospective, non-randomized study to evaluate the performance of the MyoScience Cryo-Touch II device for the treatment of wrinkles. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Wrinkles
- What is being tested?
- Cryo-Touch II
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Apr 2011
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 30-70 years
- Subject has a glabellar and/or forehead wrinkle rating by investigator of at least 1 at rest on the 5-point Wrinkle Scale (5WS)*
- Subject has signed IRB-approved informed consent form
Who cannot join
- Subject takes any medication or dietary supplement regularly that affects blood clotting (e.g., Coumadin, aspirin, clopidogrel) or increases the risk of bleeding/bruising
- Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites
- The investigator is unable to substantially lessen facial lines by physical separation
- Subject has undergone another facial cosmetic procedures at or above the level of the cheekbones within the past 6 months
- Subject is participating in another facial cosmetic research study
- Patient has any of following conditions:
Show all 15Show fewer
- History of facial nerve palsy
- Marked facial asymmetry
- Ptosis
- Excessive dermatochalasis
- Deep dermal scarring
- Thick sebaceous skin
- History of neuromuscular disorder
- Chronic dry eye symptoms
- Allergy or intolerance to lidocaine
Trial locations and contacts
1 site in 1 country.
United States1 site
The Aesthetics Research Center
Redwood City, California, 94063
About this study
This is a prospective, non-randomized study to evaluate the performance of the MyoScience Cryo-Touch II device for the treatment of wrinkles.
- Conditions
- Facial Wrinkles
- Being tested
- Cryo-Touch II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryo-Touch IIDevice
Percutaneous treatment with the device
| Study group | Role | What they receive |
|---|---|---|
| Cryo-Touch II | Experimental | Not described Receives: Device: Cryo-Touch II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Effectiveness and Safety Success
- Effectiveness success: an improvement in line severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point wrinkle scale
- Safety success: the absence of a device-related serious adverse event (DSAE)
Measured: Up to 4 months
Secondary outcomes (2)
Participants With One Point Improvement in Line Severity
- Investigators' rating of line severity improvement in the target area in animation at 7 days post-treatment, and at 30-day intervals for 120 days after treatment from baseline
Measured: Baseline and up to 4 months
Participants With an Improvement in Global Appearance
- Subjects' global assessment of change in appearance of target area at 7 days post-treatment, and at 30-day intervals for 120 days after treatment to baseline
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJan 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Facial WrinklesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 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
- NCT01167140
- Sponsor's protocol ID
- MS-4000
- Status last verified
- Jan 2024
- First submitted
- 20 Jul 2010
- Last updated
- 24 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryo-Touch II for the Treatment of Wrinkles
- ClinicalTrials.gov ID
- NCT01167140
- Acronym / sponsor ID
- MS-4000
- Conditions
- Facial Wrinkles
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 22 Jul 2010 (estimated)
- Results
- Posted 1 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, non-randomized study to evaluate the performance of the MyoScience Cryo-Touch II device for the treatment of wrinkles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryo-Touch II | Experimental | Device: Cryo-Touch II |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 30-70 years
- Subject has a glabellar and/or forehead wrinkle rating by investigator of at least 1 at rest on the 5-point Wrinkle Scale (5WS)*
- Subject has signed IRB-approved informed consent form
Key exclusion criteria (15 listed)
- Subject takes any medication or dietary supplement regularly that affects blood clotting (e.g., Coumadin, aspirin, clopidogrel) or increases the risk of bleeding/bruising
- Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites
- The investigator is unable to substantially lessen facial lines by physical separation
- Subject has undergone another facial cosmetic procedures at or above the level of the cheekbones within the past 6 months
- Subject is participating in another facial cosmetic research study
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 |
|---|---|---|
| Cryo-Touch IIPercutaneous treatment with the device | Device | Cryo-Touch II |
Primary outcome
Number of Participants With Effectiveness and Safety Success
Time frame: Up to 4 months
* Effectiveness success: an improvement in line severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point wrinkle scale * Safety success: the absence of a device-related serious adverse event (DSAE)
2 secondary outcomes
Participants With One Point Improvement in Line Severity
Time frame: Baseline and up to 4 months
Participants With an Improvement in Global Appearance
Time frame: Up to 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 2/3 study testing Cryo-Touch II in people with Facial Wrinkles, 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 3 inclusion and 15 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 Jan 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Effectiveness and Safety Success (time frame: Up to 4 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 Jan 2024.