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Completed

NCT Number: NCT01167140

Cryo-Touch II for the Treatment of Wrinkles

This is a prospective, non-randomized study to evaluate the performance of the MyoScience Cryo-Touch II device for the treatment of wrinkles.

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Key information

Conditions

Facial Wrinkles

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The Aesthetics Research Center

Redwood City, California, 94063, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 30-70 years
  • Subject has a glabellar and/or forehead wrinkle rating by investigator of at least 1 at rest on the 5-point Wrinkle Scale (5WS)*
  • Subject has signed IRB-approved informed consent form

Exclusion criteria

  • Subject takes any medication or dietary supplement regularly that affects blood clotting (e.g., Coumadin, aspirin, clopidogrel) or increases the risk of bleeding/bruising
  • Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites
  • The investigator is unable to substantially lessen facial lines by physical separation
  • Subject has undergone another facial cosmetic procedures at or above the level of the cheekbones within the past 6 months
  • Subject is participating in another facial cosmetic research study

Patient has any of following conditions:

  • History of facial nerve palsy
  • Marked facial asymmetry
  • Ptosis
  • Excessive dermatochalasis
  • Deep dermal scarring
  • Thick sebaceous skin
  • History of neuromuscular disorder
  • Chronic dry eye symptoms
  • Allergy or intolerance to lidocaine

Treatment and study plan

Cryo-Touch II

Device

Percutaneous treatment with the device

Primary outcomes

  1. Number of Participants With Effectiveness and Safety Success

    Time frame: Up to 4 months

    • Effectiveness success: an improvement in line severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point wrinkle scale
    • Safety success: the absence of a device-related serious adverse event (DSAE)

Secondary outcomes

  1. Participants With One Point Improvement in Line Severity

    Time frame: Baseline and up to 4 months

    • Investigators' rating of line severity improvement in the target area in animation at 7 days post-treatment, and at 30-day intervals for 120 days after treatment from baseline

  2. Participants With an Improvement in Global Appearance

    Time frame: Up to 4 months

    • Subjects' global assessment of change in appearance of target area at 7 days post-treatment, and at 30-day intervals for 120 days after treatment to baseline

Sponsors and collaborators

Lead sponsor

Pacira Pharmaceuticals, Inc

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 22, 2010
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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