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

NCT01447342 | Completed Phase 2

• 1 other identifier: MS-4400
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Facial Wrinkles; Skin Aging

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

Cryo-Touch II DEVICE

Percutaneous treatment with the device

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is a male or female, 30 to 70 years old.
• Subject is willing and able to give written informed consent.
• 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.
• Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study.
• 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.

You may not qualify if:

• Subject is currently enrolled in an investigational drug or device study.
• Subject has used an investigational drug or investigational device treatment within 30 days prior to first administration of the device.
• 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.
• 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.
• Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites.
• Subject has undergone another facial cosmetic procedure at or above the level of the cheekbones within the past six (6) months.
• Subject has any of the following conditions:
• History of facial nerve palsy,
• Marked facial asymmetry,
• Ptosis,
• History of neuromuscular disorder,
• Chronic dry eye symptoms,
• Allergy or intolerance to lidocaine,
• Other local skin condition (e.g., skin infection) at target treatment site,
• Any physical or psychiatric condition that in the investigator's opinion would prevent adequate study participation.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (3)

Macro, Llc

Beverly Hills, California, 90212, United States

Location

The Aesthetics Research Center

Redwood City, California, 94063, United States

Location

Roseville Facial Plastic Surgery

Roseville, California, 95661, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: October 6, 2011
• Study Start: September 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

US (3)