Effectiveness and Safety Study of the Iovera Device for the Temporary Reduction in the Appearance of Forehead Wrinkles

Completed · Not applicable

Conditions studied: Forehead Wrinkles

In brief

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

Key facts

Study ID: NCT01950065
Run by: Pacira Pharmaceuticals, Inc
People needed: 85
Starts: 2013-09-01
Expected to finish: 2014-10-01
Last updated by the study team: 2015-03-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Roseville Facial Plastic Surgery — Roseville, California, United States
DeNova Research — Chicago, Illinois, United States
Skin Care Physicians — Chestnut Hill, Massachusetts, United States
Laser & Skin Surgery Center of NY — New York, New York, United States
Nashville Center for Laser and Facial Surgery — Nashville, Tennessee, United States
Dallas Plastic Surgery Institute — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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