Cryo-Touch III Refinement Study Investigational Plan

NCT01379365 | Completed Phase 2

• 1 other identifier: MS-4500
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Facial Wrinkles; Skin Aging

Keywords

wrinkle rhytid aging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Wrinkle Severity

  Up to 4 months

• Independent Assessment

  Up to 4 months

• Global assessment

  Up to 4 months

Study Arms (1)

Treatment

EXPERIMENTAL

Device: Cryo-Touch III

Interventions

Cryo-Touch III DEVICE

Percutaneous treatment with the device

Treatment

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (1)

The Aesthetics Research Center

Redwood City, California, 94063, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: June 23, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

US (1)