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.

Study Overview

• Status: Completed
• Conditions: Facial Wrinkles
• Intervention / Treatment: Device: Cryo-Touch II

• Study Type: Interventional
• Enrollment (Actual): 42
• 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

Description

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

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: Cryo-Touch II	Device: Cryo-Touch II; Percutaneous treatment with the device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Effectiveness and Safety Success	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)	Up to 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants With One Point Improvement in Line Severity	• 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	Baseline and up to 4 months
Participants With an Improvement in Global Appearance	• 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	Up to 4 months

Collaborators and Investigators

• Sponsor: Pacira Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: July 20, 2010
• First Submitted That Met QC Criteria: July 21, 2010
• First Posted (Estimated): July 22, 2010

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MS-4000