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Completed

NCT Number: NCT01379365

Cryo-Touch III Refinement Study Investigational Plan

This is a prospective, non-randomized study to evaluate the performance of the MyoScience Cryo-Touch III device for the treatment of glabellar and/or forehead wrinkles.

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Key information

Conditions

Facial Wrinkles Skin Aging

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 2 in animation on the 5-point Wrinkle Scale (5WS)*
  • Subject has signed institutional review board (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
  • Other local skin condition (eg, skin infection) at target treatment site
  • Any physical or psychiatric condition that in the investigator's opinion would prevent adequate study participation

Treatment and study plan

Cryo-Touch III

Device

Percutaneous treatment with the device

Primary outcomes

  1. Wrinkle Severity and incidence of device-related serious adverse events

    Time frame: Up to 4 months

    • Effectiveness endpoint: Wrinkle severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point grading scale.
    • Safety endpoint: Incidence of device-related serious adverse events (DSAE).

Secondary outcomes

  1. Wrinkle Severity

    Time frame: Up to 4 months

    • Investigators' rating of wrinkle severity in the target area in animation immediately post-treatment, at 1 and 7 days post-treatment and at 30-day intervals for 120 days after treatment

  2. Independent Assessment

    Time frame: Up to 4 months

    • Independent reviewers' ratings of forehead wrinkle severity at rest and in animation at 30-days post-treatment

  3. Global assessment

    Time frame: Up to 4 months

    • Subjects' global assessment of change in appearance of target area immediately post-treatment, at 1 and 7 days post-treatment and at 30-day intervals for 120 days after treatment

Sponsors and collaborators

Lead sponsor

Pacira Pharmaceuticals, Inc

Industry

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 23, 2011
Registry last updated
Mar 24, 2015

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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