Glabellar Frown Lines Clinical Trial
Official title:
A Prospective Study Evaluating the Treatment of Forehead and/or Glabellar Lines Utilizing Optimized Algorithms With the Cryo-Touch IV Device
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.
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.
;
Observational Model: Case-Only, Time Perspective: Prospective
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