Clinical trial NCT01950065: Effectiveness and Safety Study of the Iovera Device for the Temporary Reduction in the Appearance of Forehead Wrinkles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Forehead Wrinkles
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2013-09-25
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the effectiveness and safety of the iovera device for the temporary reduction in the appearance of forehead wrinkles.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 65 years
* Subject has a forehead wrinkle rating by the Investigator/designee of at least "2" in full contraction on the 5-point Wrinkle Scale (5WS) as rated by the study Investigator, which, upon physical manipulation/separation of the skin, demonstrates a reduction in wrinkle severity
* Subject has a glabella wrinkle rating by the Investigator/designee of at least "1" in full contraction on the 5-point Glabella Scale (5GS)
* Subject has at least a 2 point difference between resting and dynamic forehead wrinkle scores using the 5-point Wrinkle Scale (5WS) as rated by the Investigator/designee
* Subject has Fitzpatrick Skin Type I, II, III, or IV (see Error! Reference source not found.)
* Subject understands and commits to comply with study requirements
* Subject is in good general health and free of any condition that could impair either complete study participation or evaluation of forehead wrinkle rating
* Subject is willing and able to give written informed consent

Exclusion Criteria:

* Subject has a clotting disorder or coagulopathy that requires regular use of an anticoagulant and/or antiplatelet therapy (e.g., warfarin, clopidogrel, etc.)
* Subject has used aspirin or any non-steroidal anti-inflammatory drugs (NSAIDs) within seven (7) days prior to screening or use of the device
* Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites
* Subject has undergone another surgical cosmetic procedure or botulinum toxin injection at or above the level of the zygoma (cheekbones) within the past six (6) months prior to screening
* Subject has a resting wrinkle score of "3" or higher on the 5WS as rated by the study Investigator
* Subject actively elevates forehead during rest
* Subject has been treated with any fillers listed in Error! Reference source not found. in the temple or forehead area in the time intervals specified prior to screening
* Subject has any of the following conditions:

  * Dermatochalasis with \<2mm lid margin when looking straight ahead
  * Excessive skin laxity/skin aging
  * Asymmetry in the upper face
  * History of facial nerve palsy
  * Eyebrow or eyelid ptosis
  * History of neuromuscular disorder
  * Chronic dry eye symptoms
  * Allergy or intolerance to local anesthetic agents (e.g., Lidocaine)
  * Use of narcotic medications for a chronic pain condition
  * Other clinically significant local skin condition (e.g., skin infection) at target treatment site
  * Any physical or psychiatric condition that in the Investigator's opinion would prevent treatment or adequate study participation
  * Chronic medical condition that in the Investigator's opinion would affect study participation (such as diabetes, hepatitis, HIV, etc.)
  * Known diagnosis of cryoglobulinemia, paroxysmal cold hemoglobinuria, or cold urticaria
  * 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
* Fitzpatrick Skin Type V or VI (see Table 3)
* Subject currently enrolled in an investigational drug, biologic or device study that could affect the safety or effectiveness of wrinkle treatment

Primary outcomes:
measure: Improvement on the 5-point Wrinkle Scale
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Roseville
country: United States
facility: Roseville Facial Plastic Surgery
state: California
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
city: Chestnut Hill
country: United States
facility: Skin Care Physicians
state: Massachusetts
city: New York
country: United States
facility: Laser & Skin Surgery Center of NY
state: New York
city: Nashville
country: United States
facility: Nashville Center for Laser and Facial Surgery
state: Tennessee
city: Dallas
country: United States
facility: Dallas Plastic Surgery Institute
state: Texas
Study officials:
References: