CompletedInterventionalNot ApplicableUpdated Mar 12, 2026
Cryo-Touch III Refinement Study Investigational Plan | NCT01379365 | Trialant
CompletedInterventionalPhase 2Phase 3Updated Mar 24, 2015
Cryo-Touch III Refinement Study Investigational Plan
ClinicalTrials.gov ID
NCT01379365
Lead Sponsor
Pacira Pharmaceuticals, IncINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2Phase 3
Enrollment
88Actual
Last Update Posted
Mar 24, 2015Estimated
Start Date
Jun 2011
Primary Completion Date
Dec 2014Actual
Completion Date
Dec 2014Actual
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.
Facial Wrinkles
Skin Aging
Cryo-Touch III
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
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