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.

Study Overview

• Status: Completed
• Conditions: Skin Aging; Facial Wrinkles
• Intervention / Treatment: Device: Cryo-Touch III

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • The Aesthetics Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment	Device: Cryo-Touch III; Percutaneous treatment with the device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wrinkle Severity and incidence of device-related serious adverse events	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).	Up to 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wrinkle Severity	• 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	Up to 4 months
Independent Assessment	• Independent reviewers' ratings of forehead wrinkle severity at rest and in animation at 30-days post-treatment	Up to 4 months
Global assessment	• 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	Up to 4 months

Collaborators and Investigators

• Sponsor: Pacira CryoTech, Inc., a wholly owned subsidiary of Pacira BioSciences, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 20, 2011
• First Submitted That Met QC Criteria: June 21, 2011
• First Posted (Estimate): June 23, 2011

Study Record Updates

• Last Update Posted (Estimate): March 24, 2015
• Last Update Submitted That Met QC Criteria: March 23, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: wrinkle rhytid aging
• Other Study ID Numbers: MS-4500