A Study to Evaluate the Safety and Effectiveness of the Cryo-Touch II Device for the Treatment of Forehead and/or Glabellar Lines

Skin Aging Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01447342
• Other study ID #: MS-4400
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 29, 2011
• Last updated: March 23, 2015
• Start date: September 2011
• Est. completion date: August 2012

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

A prospective, non-randomized, multicenter study to evaluate the safety and effectiveness of the cryo-touch II device for the treatment of forehead and/or glabellar lines

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Subject is a male or female, 30 to 70 years old.

2. Subject is willing and able to give written informed consent.

3. Subject has a forehead wrinkle rating by the investigator/designee of at least "2" in animation on the 5-point Wrinkle Scale (5WS) which upon physical manipulation/separation of the skin demonstrates a reduction in wrinkle severity. Subject may also have a glabellar score of "1" or higher in animation on a 4-point scale.

4. Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study.

5. Subject is in good general health and free of any disease state or physical condition that might impair evaluation of forehead and/or glabellar wrinkle rating or which, in the investigator's opinion, exposes the subject to an unacceptable risk by study participation.

Exclusion Criteria:

1. Subject is currently enrolled in an investigational drug or device study.

2. Subject has used an investigational drug or investigational device treatment within 30 days prior to first administration of the device.

3. Subject has a clotting disorder or has used an anticoagulant (e.g., Coumadin, clopidogrel, etc.) within seven (7) days prior to administration of the device.

4. Subject has used aspirin, or non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen, and naproxen) within seven (7) days prior to administration of the device.

5. Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites.

6. Subject has undergone another facial cosmetic procedure at or above the level of the cheekbones within the past six (6) months.

7. Subject has any of the following conditions:

1. History of facial nerve palsy,

2. Marked facial asymmetry,

3. Ptosis,

4. History of neuromuscular disorder,

5. Chronic dry eye symptoms,

6. Allergy or intolerance to lidocaine,

7. Other local skin condition (e.g., skin infection) at target treatment site,

8. Any physical or psychiatric condition that in the investigator's opinion would prevent adequate study participation.

9. Chronic medical condition that in the investigator's opinion would affect study participation (such as diabetes, hepatitis, HIV, etc.).

10. Any chronic condition contraindicated for the use of nerve mapping device including heart disease, use of a cardiac pacemaker, and pregnancy.

8. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.

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 II
Percutaneous treatment with the device

Locations

Country	Name	City	State
United States	Macro, Llc	Beverly Hills	California
United States	The Aesthetics Research Center	Redwood City	California
United States	Roseville Facial Plastic Surgery	Roseville	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	Effectiveness success	Effectiveness endpoint: wrinkle severity in the forehead in animation at 30 days post-treatment (Visit 5) as rated by the investigator/designee using the 5-point Wrinkle Scale (5WS).	Up to 4 months	No
Primary	Safety success	Safety endpoint: Tolerability of treatment (LSRs), local and systemic adverse events will be assessed at all visits. Incidence of serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) will be recorded. A serious adverse event is one that meets the ISO definition of SAE .	Up to 4 months	Yes