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

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

Conditions
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Forehead Wrinkles

Intervention / Treatment
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* Device: iovera


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Treatment with iovera<br>Immediate treatment with iovera | Device: iovera<br> <br> |
| Active Comparator: Delayed Treatment with iovera<br>Delayed Treatment with iovera | Device: iovera<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement on the 5-point Wrinkle Scale |  | 30 Days |