Prospective Study Evaluating the Treatment of Hyperdynamic Forehead Wrinkles

March 23, 2015 updated by: Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.

A Prospective Study Evaluating the Treatment of Hyperdynamic Forehead Wrinkles Utilizing the Iovera With Blunt Tip Cannula Smart Tip

To evaluate the safety and effectiveness of the iovera° device with the blunt tip cannula for the treatment of forehead wrinkles.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Redwood City, California, United States, 94043
        • The Aesthetics Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy subjects, male or female, age 18 - 65 with forehead wrinkles deemed significant per protocol inclusion criteria.

Description

Inclusion Criteria:

  • Male or Females 18-65 years of age.
  • Forehead wrinkle(s) rating of at least 2 in animation on the 5-point Wrinkle Scale (5WS) which upon physical manipulation of the skin demonstrates a reduction in wrinkle severity.
  • Subject has at least a 2 point difference between resting and dynamic forehead wrinkle scores using the 5WS.
  • Glabellar wrinkle score of "1" or higher in animation on the 5-point Glabella Scale (5GS).
  • Fitzpatrick Skin Type I, II, III, or IV.
  • Subject has consented and agreed to participate in all study procedures and visits for the study's duration.
  • Subject is in good general health, 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:

  • Subject has a clotting disorder or coagulopathy that requires use of an anticoagulant and/or antiplatelet therapy (e.g., warfarin, clopidigrel, etc.)
  • Subject has used medication or supplements affecting clotting cascade (e.g., aspirin, fish oil, etc.), or non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen and naproxen) within seven (7) days prior to administration 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 administration of the device.
  • Subject has a resting wrinkle score of "3" or higher on the 5WS.
  • Subjects who actively elevate forehead at rest.
  • Subject has been treated with fillers in the temple or forehead area in the time intervals specified prior to the start of their participation in the study.

  • Subject has any of the following:

    1. Dermatochalasis with <1mm lid margin when looking straight ahead.
    2. Excessive skin laxity.
    3. Asymmetry in the upper face.
    4. History of facial nerve palsy.
    5. Eyebrow or eyelid ptosis.
    6. History of neuromuscular disorder.
    7. Chronic dry eye symptoms.
    8. Allergy or intolerance to local anesthetic agents (e.g., Lidocaine).
    9. Use of narcotic medication for a chronic pain condition.
    10. Any other clinically significant, in the opinion of the Investigator, local skin condition (e.g., skin infection) at target treatment site that may interfere or be a safety concern.
    11. Any physical or psychiatric condition that in the Investigator's opinion would prevent adequate study participation.
    12. Chronic medical condition that in the Investigator's opinion would affect study participation (such as uncontrolled hypertension, diabetes, hepatitis, HIV, etc.).

    13. Diagnosis of:

      • Cryoglobinemia
      • Paroxysmal cold hemoglobinuria
      • Cold Uticaria
      • Raynaud's Disease
      • Open and/or infected wounds
      • Existing neuromuscular disease
    14. Fitzpatrick Skin Type V or IV
    15. Subject is currently enrolled in an investigational drug, biologic or device study that could affect the safety or effectiveness of the iovera° treatment.
    16. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Blunt Tip Cannula
Device: Cryotherapy for the utilization of wrinkle reduction (iovera)
Other Names:
  • iovera

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Wrinkle severity when eyebrows are elevated at 30 days post-treatment.
Time Frame: 120 Days
120 Days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Anticipated observations, adverse events and SAEs/UADEs will be assessed at each visit.
Time Frame: 120 Days
120 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MYO-0834

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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