NanoSilk Cosmo: Evaluation of a Novel Silk Complex on Biophysical Parameters Related to Skin Aging
Condition: Aging
Study type: Interventional

Summary: 
      Silk is a naturally occurring protein polymer that is approved for medical use by the U.S
      Food and Drug Administration (FDA). Silk fibroin fiber biomaterial has shown promising
      results for tissue regeneration demonstrated through in vivo and in vitro animal models. The
      investigators of this study have previously shown that patients' report improvement in common
      skin aging findings including wrinkles, sagginess, and dry skin. The investigators will
      continue this assessment of patients' skin perception as well as add on objective measures of
      skin resilience, elasticity, and hydration.

      The investigators will provide participants with a demographic survey, and the FACE-Q survey,
      a validated survey, prior to administration of NanoSilk Cosmo, to assess perception of aging,
      satisfaction with facial appearance, satisfaction with skin. The participant will undergo
      baseline evaluation of several objective measures of skin hydration, elasticity and overall
      healthy using non-invasive devices (Courage+Khazaka Corneometer Probe, Courage+Khazaka
      Electronic GmbH Cutometer Dual MPA 580, and VISIA-CA GEN 7). The participants will be
      provided with 30ml of the NanoSilk Cosmo and with extensive instruction on administration of
      the product.

      Participants will return to clinic after 4 weeks of using the product to perform the FACE-Q
      and re-evaluation of several objective measures of the skin using non-invasive devices
      (Courage+Khazaka Corneometer Probe, Courage+Khazaka Electronic GmbH Cutometer Dual MPA 580,
      and VISIA-CA GEN 7).
    

Detailed description: 
      Skin aging is characterized by atrophy, decreased elasticity, wrinkling, impaired strength,
      and altered metabolic and reparative responses. The etiology of these changes is
      multifactorial and includes intrinsic factors such as age, genetics, metabolism, and
      nutrition, as well as extrinsic or environmental effects like Ultraviolet (UV) radiation and
      air pollution. It has been noted that there is increased fragility of the skin with age due
      to flattening of the dermo-epidermal junction and decreased biosynthetic capacity of
      fibroblasts, all leading to decreased skin resilience and an undesirable cosmetic appearance
      of the skin.

      Recently, the use of silk to reverse or repair some of these aging processes has gained
      significant interest. Silk is a natural protein polymer that is approved for medical use by
      the U.S. Food and Drug Administration and Bombyx mori (B. mori) silk is considered a
      non-animal product (EU Council Directive 93/42/EEC, rule 17). Importantly it is
      biocompatible, non-inflammatory, and non-cytotoxic. There are two important components of
      silk that are derived from the B. mori worm, both of which are proteins - fibroin and
      sericin. In simple terms, sericin, which represents about 30% of the entire cocoon, functions
      as a glue to hold the fibroin fibers together while blocking UV rays and providing moisture.
      The fibroin, approximately 70% of the cocoon, is composed of two proteins which interestingly
      have similar amino acid compositions to Natural Moisturizing Factor which is found in the
      stratum corneum of human skin and helps retain moisture in the skin. The stratum corneum is
      of key importance to the skin's ability to hold water and maintain skin integrity which is
      critical for maintaining a youthful appearance.

      Besides the moisture retention effects noted above, one of the theories behind the
      effectiveness of silk on the skin is that the silk fibroin nanofibers are able to promote
      cell adhesion and allows type I collagen to spread within epidermal keratinocytes and
      fibroblasts. New data suggest that if a patient has a higher ratio of collagen type I to
      collagen type III that these patients will have better outcomes after aesthetic facial
      surgery, which highlights the key role of collagen in the skin.

      The investigators will provide participants with the FACE-Q survey, a validated survey, prior
      to administration of NanoSilk Cosmo, to assess perception of aging, satisfaction with facial
      appearance, and satisfaction with skin. The participant will undergo baseline evaluation of
      several objective measures of skin hydration, elasticity and overall healthy using
      non-invasive devices (Courage+Khazaka Corneometer Probe, Courage+Khazaka Electronic GmbH
      Cutometer Dual MPA 580, and VISIA-CA GEN 7). The participants will be provided with 30ml of
      the NanoSilk Cosmo and with extensive instruction on administration of the product.

      Participants will return to clinic after 4 weeks of using the product to perform the FACE-Q
      and re-evaluation of several objective measures of the skin using non-invasive devices
      (Courage+Khazaka Corneometer Probe, Courage+Khazaka Electronic GmbH Cutometer Dual MPA 580,
      and VISIA-CA GEN 7).

      Courage+Khazaka Corneometer Probe: By evaluating the capacitance through the skin this will
      serve as a reflection of moisture content in the skin. The corneometer is not significantly
      affected by stales or residues of topicals applied to the skin. Additionally, it provides
      very quick measurements (1 sec), continuous measurements, and the measurement depth is very
      small to capture the stratum corneum and avoid deeper skin structures (blood vessels). The
      Visioscan measures an integral characteristic of skin, and included metric in the clinical
      experiment. It is medical grade (degree of calibration) and will provide the most accurate
      data for researchers.

      The probe will be placed on the skin before and after use of NanoSilk Cosmo and measure the
      data points noted above.

      Courage+Khazaka Electronic GmbH Cutometer dual MPA 580: This device will measure
      viscoelasticity of the skin using negative pressure to mechanically deform the skin. The
      penetration depth is determined by a non-contact optical measuring system within the probe.
      The resistance of the skin to the negative pressure (firmness) and its ability to return to
      its original position (elasticity) are displayed as curves (penetration depth in mm/time) in
      real time. The measurement allows for information about the elastic and mechanical properties
      of skin surface and to objectively quantify a property of skin aging. The Cutometer measures
      an integral characteristic of skin and included metric in the clinical experiment. It is
      medical grade (degree of calibration) and will provide the most accurate data for
      researchers.

      The probe will be placed on the skin before and after use of NanoSilk Cosmo and measure the
      data points noted above.

      VISIA-CA GEN 7(Consultation System): VISIA multi-point positioning system and live image
      overlay provides complete data surface and subsurface skin conditions. Skin conditions
      included in analysis are hyperpigmentation, hypopigmentation, inflammation, wrinkles,
      topography, UV damage, vascularity (spider veins), and porphyrins.

      The participant will place their face in the instrument and have their photo taken both
      before and after use of NanoSilk Cosmo.
    

Intervention name(s): NanoSilk Cosmo
Intervention type(s): Other
Intervention description(s): Participant will receive 30 mL of NanoSilk Cosmo jar.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other