A Study to Evaluate the Safety and Effectiveness of the Cryo-Touch II Device for the Treatment of Forehead and/or Glabellar Lines

Completed · Phase 2/Phase 3

Conditions studied: Facial Wrinkles, Skin Aging

In brief

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

Key facts

Study ID

NCT01447342

Run by

Pacira Pharmaceuticals, Inc

People needed

54

Starts

2011-09-01

Expected to finish

2012-08-01

Last updated by the study team

2015-03-24

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Macro, Llc — Beverly Hills, California, United States
• The Aesthetics Research Center — Redwood City, California, United States
• Roseville Facial Plastic Surgery — Roseville, California, United States

Full record on ClinicalTrials.gov

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