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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01379365
Other study ID # MS-4500
Secondary ID MS-4500
Status Completed
Phase Phase 2/Phase 3
First received June 20, 2011
Last updated March 23, 2015
Start date June 2011
Est. completion date December 2014

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

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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 70 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Cryo-Touch III
Percutaneous treatment with the device

Locations

Country Name City State
United States The Aesthetics Research Center Redwood City 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 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 Yes
Secondary Wrinkle Severity • Investigators' rating of wrinkle severity in the target area in animation immediately post-treatment, at 1 and 7 days post-treatment and at 30-day intervals for 120 days after treatment Up to 4 months No
Secondary Independent Assessment • Independent reviewers' ratings of forehead wrinkle severity at rest and in animation at 30-days post-treatment Up to 4 months No
Secondary Global assessment • Subjects' global assessment of change in appearance of target area immediately post-treatment, at 1 and 7 days post-treatment and at 30-day intervals for 120 days after treatment Up to 4 months No
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