Cryo-Touch III Refinement Study Investigational Plan

Skin Aging Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379365
• Other study ID #: MS-4500
• Secondary ID: MS-4500
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 20, 2011
• Last updated: March 23, 2015
• Start date: June 2011
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: MyoScience, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• 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 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Facial Wrinkles
• Skin Aging

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
MyoScience, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	Independent Assessment	• Independent reviewers' ratings of forehead wrinkle severity at rest and in animation at 30-days post-treatment	Up to 4 months	No
Secondary	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	No