Study Evaluating the Treatment of Forehead and/or Glabellar Lines With the CRYO-TOUCH III Device
|ClinicalTrials.gov Identifier: NCT01808742|
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : March 24, 2015
|Condition or disease||Intervention/treatment|
|Frown Lines Glabellar Frown Lines||Device: Treatment with CryoTouch III 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 III 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 investigate optimized algorithms and ongoing safety and effectiveness.
|Study Type :||Observational|
|Actual Enrollment :||17 participants|
|Official Title:||A Prospective Study Evaluating the Treatment of Forehead and/or Glabellar Lines Utilizing Optimized Algorithms With the Cryo-Touch III Device|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||August 2014|
Treatment with CryoTouch III device
Device: Treatment with CryoTouch III Device
Bilateral forehead treatment with CryoTouch III device on the temporal branch of the facial nerve. Subject will be treated once and may be retreated up to 7 days after initial treatment.
- Effectiveness [ Time Frame: 30 days ]Wrinkle severity in the target area in animation at 30 days post-treatment as rated by the investigator using the 5-point grading scale.
- improvement rating [ Time Frame: 56 days ]Changes in from baseline assessments of wrinkle severity based on ratings by the investigator and subject.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808742
|United States, California|
|77 Plastic Surgery|
|San Francisco, California, United States, 94102|
|Principal Investigator:||Larry Fan, MD||77 Plastic Surgery|