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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01950065
Recruitment Status : Completed
First Posted : September 25, 2013
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.

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

Condition or disease Intervention/treatment Phase
Forehead Wrinkles Device: iovera Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Experimental: Immediate Treatment with iovera
Immediate treatment with iovera
Device: iovera
Active Comparator: Delayed Treatment with iovera
Delayed Treatment with iovera
Device: iovera



Primary Outcome Measures :
  1. Improvement on the 5-point Wrinkle Scale [ Time Frame: 30 Days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950065


Locations
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United States, California
Roseville Facial Plastic Surgery
Roseville, California, United States, 95661
United States, Illinois
DeNova Research
Chicago, Illinois, United States, 60611
United States, Massachusetts
Skin Care Physicians
Chestnut Hill, Massachusetts, United States, 02467
United States, New York
Laser & Skin Surgery Center of NY
New York, New York, United States, 10016
United States, Tennessee
Nashville Center for Laser and Facial Surgery
Nashville, Tennessee, United States, 37203
United States, Texas
Dallas Plastic Surgery Institute
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.

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Responsible Party: Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.
ClinicalTrials.gov Identifier: NCT01950065    
Other Study ID Numbers: MYO-0806
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015