Facial WrinklesPhase 2/3NCT01447342
A Study to Evaluate the Safety and Effectiveness of the Cryo-Touch II Device for the Treatment of Forehead and/or Glabellar Lines
A Phase 2/3 study testing Cryo-Touch II in people with Facial Wrinkles and Skin Aging, run by Pacira Pharmaceuticals, Inc at 3 sites in United States.
Trial summary
A prospective, non-randomized, multicenter study to evaluate the safety and effectiveness of the cryo-touch II device for the treatment of forehead and/or glabellar lines 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, Skin Aging
- What is being tested?
- Cryo-Touch II
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2011to Aug 2012
- Phase
- Phase 2/3
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is a male or female, 30 to 70 years old.
- Subject is willing and able to give written informed consent.
- Subject has a forehead wrinkle rating by the investigator/designee of at least "2" in animation on the 5-point Wrinkle Scale (5WS) which upon physical manipulation/separation of the skin demonstrates a reduction in wrinkle severity. Subject may also have a glabellar score of "1" or higher in animation on a 4-point scale.
- Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study.
- Subject is in good general health and free of any disease state or physical condition that might impair evaluation of forehead and/or glabellar wrinkle rating or which, in the investigator's opinion, exposes the subject to an unacceptable risk by study participation.
Who cannot join
- Subject is currently enrolled in an investigational drug or device study.
- Subject has used an investigational drug or investigational device treatment within 30 days prior to first administration of the device.
- Subject has a clotting disorder or has used an anticoagulant (e.g., Coumadin, clopidogrel, etc.) within seven (7) days prior to administration of the device.
- Subject has used aspirin, or non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen, and naproxen) within seven (7) days prior to administration of the device.
- Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites.
- Subject has undergone another facial cosmetic procedure at or above the level of the cheekbones within the past six (6) months.
Show all 18Show fewer
- Subject has any of the following conditions:
- History of facial nerve palsy,
- Marked facial asymmetry,
- Ptosis,
- History of neuromuscular disorder,
- Chronic dry eye symptoms,
- Allergy or intolerance to lidocaine,
- Other local skin condition (e.g., skin infection) at target treatment site,
- Any physical or psychiatric condition that in the investigator's opinion would prevent adequate study participation.
- Chronic medical condition that in the investigator's opinion would affect study participation (such as diabetes, hepatitis, HIV, etc.).
- Any chronic condition contraindicated for the use of nerve mapping device including heart disease, use of a cardiac pacemaker, and pregnancy.
- Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Macro, Llc
Beverly Hills, California, 90212
The Aesthetics Research Center
Redwood City, California, 94063
Roseville Facial Plastic Surgery
Roseville, California, 95661
About this study
A prospective, non-randomized, multicenter study to evaluate the safety and effectiveness of the cryo-touch II device for the treatment of forehead and/or glabellar lines
- Conditions
- Facial Wrinkles, Skin Aging
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness success
Effectiveness endpoint: wrinkle severity in the forehead in animation at 30 days post-treatment (Visit 5) as rated by the investigator/designee using the 5-point Wrinkle Scale (5WS).
Measured: Up to 4 months
Safety success
Safety endpoint: Tolerability of treatment (LSRs), local and systemic adverse events will be assessed at all visits. Incidence of serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) will be recorded. A serious adverse event is one that meets the ISO definition of SAE .
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 posted6 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 54 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
- NCT01447342
- Sponsor's protocol ID
- MS-4400
- Status last verified
- Mar 2015
- First submitted
- 29 Sep 2011
- 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
- A Study to Evaluate the Safety and Effectiveness of the Cryo-Touch II Device for the Treatment of Forehead and/or Glabellar Lines
- ClinicalTrials.gov ID
- NCT01447342
- Acronym / sponsor ID
- MS-4400
- Conditions
- Facial Wrinkles, Skin Aging
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 6 Oct 2011 (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, multicenter study to evaluate the safety and effectiveness of the cryo-touch II device for the treatment of forehead and/or glabellar lines
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is a male or female, 30 to 70 years old.
- Subject is willing and able to give written informed consent.
- Subject has a forehead wrinkle rating by the investigator/designee of at least "2" in animation on the 5-point Wrinkle Scale (5WS) which upon physical manipulation/separation of the skin demonstrates a reduction in wrinkle severity. Subject may also have a glabellar score of "1" or higher in animation on a 4-point scale.
- Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study.
- Subject is in good general health and free of any disease state or physical condition that might impair evaluation of forehead and/or glabellar wrinkle rating or which, in the investigator's opinion, exposes the subject to an unacceptable risk by study participation.
Key exclusion criteria (18 listed)
- Subject is currently enrolled in an investigational drug or device study.
- Subject has used an investigational drug or investigational device treatment within 30 days prior to first administration of the device.
- Subject has a clotting disorder or has used an anticoagulant (e.g., Coumadin, clopidogrel, etc.) within seven (7) days prior to administration of the device.
- Subject has used aspirin, or non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen, and naproxen) within seven (7) days prior to administration of the device.
- Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites.
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 | – |
Primary outcome
Effectiveness success
Time frame: Up to 4 months
Effectiveness endpoint: wrinkle severity in the forehead in animation at 30 days post-treatment (Visit 5) as rated by the investigator/designee using the 5-point Wrinkle Scale (5WS).
Safety success
Time frame: Up to 4 months
Safety endpoint: Tolerability of treatment (LSRs), local and systemic adverse events will be assessed at all visits. Incidence of serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) will be recorded. A serious adverse event is one that meets the ISO definition of SAE .
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.
3 sites 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 and Skin Aging, run by Pacira Pharmaceuticals, Inc at 3 sites 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 5 inclusion and 18 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 3 sites 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?
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?
Effectiveness success (time frame: Up to 4 months). The study lists 2 primary outcomes in all. 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.