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 range30 Years – 70 Years
SexALL
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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.
✕. 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.