Clinical trial NCT01447342: A Study to Evaluate the Safety and Effectiveness of the Cryo-Touch II Device for the Treatment of Forehead and/or Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Facial Wrinkles
Skin Aging
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2011-10-06
Enrollment: 54
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

1. Subject is a male or female, 30 to 70 years old.
2. Subject is willing and able to give written informed consent.
3. 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.
4. Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study.
5. 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:

1. Subject is currently enrolled in an investigational drug or device study.
2. Subject has used an investigational drug or investigational device treatment within 30 days prior to first administration of the device.
3. 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.
4. 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.
5. Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites.
6. Subject has undergone another facial cosmetic procedure at or above the level of the cheekbones within the past six (6) months.
7. Subject has any of the following conditions:

   1. History of facial nerve palsy,
   2. Marked facial asymmetry,
   3. Ptosis,
   4. History of neuromuscular disorder,
   5. Chronic dry eye symptoms,
   6. Allergy or intolerance to lidocaine,
   7. Other local skin condition (e.g., skin infection) at target treatment site,
   8. Any physical or psychiatric condition that in the investigator's opinion would prevent adequate study participation.
   9. Chronic medical condition that in the investigator's opinion would affect study participation (such as diabetes, hepatitis, HIV, etc.).
   10. Any chronic condition contraindicated for the use of nerve mapping device including heart disease, use of a cardiac pacemaker, and pregnancy.
8. 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.

Primary outcomes:
measure: Effectiveness success
timeFrame: Up to 4 months
measure: Safety success
timeFrame: Up to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Macro, Llc
state: California
city: Redwood City
country: United States
facility: The Aesthetics Research Center
state: California
city: Roseville
country: United States
facility: Roseville Facial Plastic Surgery
state: California
Study officials:
References: