A Study to Evaluate the Safety and Effectiveness of the Cryo-Touch II Device for the Treatment of… (NCT01447342) | Clinical Trial Compass
CompletedPhase 2/3
A Study to Evaluate the Safety and Effectiveness of the Cryo-Touch II Device for the Treatment of Forehead and/or Glabellar Lines
United States54 participantsStarted 2011-09
Plain-language 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
Who can participate
Age range
30 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.