Cryo-Touch II for the Treatment of Wrinkles

Facial Wrinkles Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167140
• Other study ID #: MS-4000
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 2010
• Est. completion date: April 2011

Study information

• Verified date: January 2024
• Source: Pacira Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Facial Wrinkles

Intervention

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

Locations

Country	Name	City	State
United States	The Aesthetics Research Center	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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