Cryo-Touch III Refinement Study Investigational Plan

Pacira

Status and phase

Completed

Phase 3

Phase 2

Conditions

Skin Aging

Facial Wrinkles

Treatments

Device: Cryo-Touch III

Study type

Interventional

Funder types

Industry

Identifiers

NCT01379365

MS-4500

Details and patient eligibility

About

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.

Enrollment

88 patients

Sex

All

Ages

30 to 70 years old

Volunteers

Accepts Healthy Volunteers

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