A Prospective Study Evaluating the Treatment of Forehead and/or Glabellar Lines With the Cryo-Touch IV Device

NCT01801826 | Completed

• 1 other identifier: MYO-0726
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 2

Brief Summary

myoscience Inc. (Redwood City, CA) has developed a device for a novel, minimally invasive facial rejuvenation procedure designed to soften hyperdynamic facial lines. The myoscience Cryo-Touch IV device uses well-established principles of cryobiology to cause localized reduction in muscle activity resulting in a reversible reduction in facial animation and the appearance of facial lines. The device operates on well-established cryobiology principles; that localized exposure to controlled low temperature conditions can alter tissue function. The therapy treats targeted motor nerves with low temperatures via a cold probe in the form of an assembly of small diameter needles, creating a highly localized treatment zone around the probe. The thermal algorithm is designed to produce a reversible loss of nerve conduction resulting in a temporary decrease in muscle contractility. Prior studies of Cryo-Touch, Cryo-Touch II and Cryo-Touch III have provided strong evidence of effectiveness and safety for applications in this indication. The goal of the study described herein is to show the safety and effectiveness of this approach using the Cryo-Touch IV device.

Conditions

Frown Lines; Glabellar Frown Lines

Outcome Measures

Primary Outcomes (1)

• Effectiveness

  Wrinkle severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point grading scale.

  30 days

Secondary Outcomes (1)

• Improvement ratings

  30

Study Arms (1)

Treatment

Treatment with CryoTouch IV device

Device: Treatment with CryoTouch IV

Interventions

Treatment with CryoTouch IV DEVICE

Bilateral forehead treatment with the Cryo-Touch IV device on the temporal branch of the facial nerve. Subject will be treated once and may have a retreatment up to 7 days after the first treatment

Treatment

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects, male or female, age 30 - 65 with forehead and/or glabellar lines deemed significant per protocol inclusion criteria.

You may qualify if:

• \. Male or Females 30-65 years of age. 2. Forehead wrinkle(s) rating of at least 2 in animation on the 5-point Wrinkle Scale (5WS) which upon physical manipulation of the skin demonstrates a reduction in wrinkle severity.
• \. Glabellar wrinkle score of "1" or higher in animation on the 5-point Glabella Scale (5GS).
• \. Fitzpatrick Skin Type I, II, III, or IV. 5. Subject has consented and agreed to participate in all study procedures and visits for the study's duration.
• \. Subject is in good general health, 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:

• \. Dermatochalasis with \<1mm lid margin when looking straight ahead. 2. Excessive skin laxity. 3. Asymmetry in the upper face. 4. Subjects who actively elevate during a rest cycle. 5. History of facial nerve palsy. 6. Eyebrow or eyelid ptosis. 7. History of neuromuscular disorder. 8. Chronic dry eye symptoms. 9. Allergy or intolerance to lidocaine. 10. Any other clinically significant, in the opinion of the investigator, local skin condition (e.g., skin infection) at target treatment site that may interfere or be a safety concern.
• \. Any physical or psychiatric condition that in the investigator's opinion would prevent adequate study participation.
• \. Chronic medical condition that in the investigator's opinion would affect study participation (such as uncontrolled hypertension, diabetes, hepatitis, HIV, etc.).
• \. Diagnosis of cryoglobulinemia, paroxysmal cold hemoglobinuria, or cold urticaria.
• \. 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 is known to be noncompliant or is unlikely to comply with the requirements of the study protocol in the opinion of the investigator.
• \. Subject has undergone another surgical cosmetic procedure or botulinum toxin injection at or above the level of the zygoma (cheekbones) within the past six (6) months prior to administration of the device.
• \. Subject has been treated with fillers (see Section 2.8 Table 1) in the temple or forehead area in the time intervals specified prior to the start of their participation in the study.
• \. Subject has a resting wrinkle score of "2" or higher on the 5WS.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (2)

Beverly Hills International Center for Aesthetic Surgery

Beverly Hills, California, 90211, United States

Location

77 Plastic Surgery

San Francisco, California, 943102, United States

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

• Larry K Fan, MD

  77 Plastic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: March 1, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 24, 2015

Record last verified: 2013-03

Locations

US (2)