A Prospective Study Evaluating the Treatment of Forehead and/or Glabellar Lines With the Cryo-Touch IV Device
Condition: Frown Lines; Glabellar Frown Lines
Study type: Observational

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.
    

Detailed description: 
      The development of facial rhytids or wrinkles is a natural part of the aging process,
      resulting from the thinning of the dermis and epidermis due to a loss of elastic fibers and
      collagen and subcutaneous fat loss. Contributors to the formation of facial rhytids include
      exposure to ultraviolet light (sunlight) and gravity, as well as habitual facial expressions
      which cause lines to occur in specific facial regions as the skin loses elasticity. In some
      cases, hyperdynamic activity of underlying facial muscles leads to the development of furrows
      in the glabella and frontalis areas. Activity of the facial muscles causes hyperdynamic lines
      independent of the aging process and this can also be undesirable.

      With an aging population, the demand for facial rejuvenation techniques has increased. A
      range of treatment options have been developed to provide reduction in facial lines,
      including topical medications, neuromuscular inhibiting injections, laser treatments,
      cosmetic fillers, and surgical facelifts. Those options targeted specifically at hyperdynamic
      furrows include botulinum toxin injection, injectable fillers, and surgical resection of
      facial muscles or division of motor nerves. Although botulinum toxin injections have become a
      popular approach to reduction of glabellar lines by providing partial chemical denervation of
      the glabellar muscle complex, safety concerns exist related to the use of this toxin.
      Injectable fillers do not mitigate the underlying muscular activity which produces the facial
      furrows. Surgical strategies are limited by the risks and complications typically associated
      with surgery, including bleeding, bruising, scarring, and infection. A non-surgical,
      minimally invasive approach to elimination of facial hyperdynamic lines which avoids the use
      of chemical toxins is desirable.

      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.
    

Intervention name(s): Treatment with CryoTouch IV
Intervention type(s): Device
Intervention description(s): 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
Observational model: Case-Only
Time perspective: Prospective
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.