Radio Frequency Microneedling for Suprapatellar Skin
Condition: Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      The human skin aging process is characterized by thinning dermis, atrophy of the
      extracellular matrix, and reduced collagen synthesis. Loss of collagen in the dermis is of
      aesthetic concern, as it is the main structural support in the dermis and its loss results in
      skin laxity. Photo-damaged skin, mostly due to UVR, causes degradation of elastic fibers.
      This is histologically seen as disorganized tangles of elastin. Additionally, as humans age,
      skin tends to appear more dry due to its poor hydration and turgor capacity. The use of
      minimally invasive aesthetic treatments in reducing signs of aging has been gaining in
      popularity over surgical treatments in recent years. Several energy types including, laser,
      radiofrequency, infrared, and ultrasound, have been developed for facial rejuvenation. These
      treatments induce controlled thermal damage into the dermis and cause collagen contraction
      and neocollagenesis resulting in skin tightening over several months. For improving
      appearance of other anatomical areas, micro-focused ultrasound has been the preferred method,
      but has shown limited success in tightening the suprapatellar skin.

      As with facial skin aging, the suprapatellar skin loses elasticity with age and begins to
      sag. Noninvasive treatments used for the face may also be used in other anatomical areas to
      produce the same effects of tightening. Minimally invasive bipolar radiofrequency produces a
      controlled thermal injury in a fractional manner without damaging the dermal-epidermal
      junction, epidermis or subcutis. Radiofrequency, unlike lasers, are chromophore-independent
      providing better penetration than lasers, and spare sweat glands, sebaceous glands, and hair
      follicles.
    

Detailed description: 
      The Profound System is a bipolar fractional radiofrequency device which uses microneedles and
      thermal heat to stimulate neocollagenesis. Based on the its effect on facial skin, it can be
      hypothesized that bipolar fractional radiofrequency will stimulate similar effect on
      suprapatellar skin, lifting and reducing laxity of the skin in that region.

      This study intends to evaluate the effectiveness of the Profound System on suprapatellar
      skin, which has been FDA approved for treatment of facial wrinkles and improvement in the
      appearance of cellulite. This device is a well studied and frequently used on facial skin,
      however, there are no studies showing its effectiveness elsewhere on the body.

      There are alternative treatments that have been shown to decrease laxity of the suprapatellar
      skin, however, the studies include a small and limited population, and have not produced the
      desired effects in practice. The Profound device may be able to produce clinically
      significant improvement in laxity of the suprapatellar skin.
    

Intervention name(s): Profound system
Intervention type(s): Device
Intervention description(s): Profound system is a bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis. Based on the its effect on facial skin, it can be hypothesized that bipolar fractional radiofrequency will stimulate similar effect on suprapatellar skin, lifting and reducing laxity of the skin in that region. Bilateral suprapatellar regions will be identified and marked for treatment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: knee area; suprapatellar skin; aging; laxity