Phase 3
Completed N=42
Cryo-Touch II for the Treatment of Wrinkles
Facial Wrinkles
Source: ClinicalTrials.gov NCT01167140 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcomePrimary: Number of Participants With Effectiveness and Safety Success — 30; 41 participants
Summary
This is a prospective, non-randomized study to evaluate the performance of the MyoScience Cryo-Touch II device for the treatment of wrinkles.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Effectiveness and Safety Success |
30; 41 | — |
| SECONDARY Participants With One Point Improvement in Line Severity |
32; 19; 9; 2 | — |
| SECONDARY Participants With an Improvement in Global Appearance |
34; 32; 25; 12; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Age 30-70 years
- Subject has a glabellar and/or forehead wrinkle rating by investigator of at least 1 at rest on the 5-point Wrinkle Scale (5WS)*
- Subject has signed 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
Data sourced from ClinicalTrials.gov (NCT01167140). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.