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

NCT04630418 | Completed

• 1 other identifier: 20-2033
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Aging

Outcome Measures

Primary Outcomes (4)

• Subjective patient perception of skin

  Evaluate patient's perception of satisfaction with skin before and after application of NanoSilk Cosmo using surveys designed to target and answer these questions. Copies of these surveys are below. Scale Titles: NanoSilk Cosmo Initial Survey and NanoSilk Cosmo Completion Survey There are no minimum or maximum values of this scale, therefore there is no high or low score. This is a scale to determine the demographics and use patterns of those who use NanoSilk Cosmo. Additionally, it will give the option for feedback on the product and ask participants to evaluate the effect the product had on their skin.

  6 months

• Change in skin hydration levels

  To perform a prospective clinical trial to quantitatively assess the effects of NanoSilk Cosmo solution on the hydration status of the skin using the Courage + Khazaka Electronic Corneometer which uses a capacitance measurement of a dielectric medium that changes with increased or decreased hydration in the stratum corneum layer of the skin.

  6 months

• Change in skin viscoelasticity levels

  To perform a prospective clinical trial to quantitatively assess the effects of NanoSilk Cosmo solution on the viscoelasticity of the skin using the Courage + Khazaka Electronic GmbH Cutometer which uses negative pressure to deform the skin and then measures its ability to return to the original position. These measurements are then displayed on a curve for which normal skin has been previously established.

  6 months

• Change in skin surface topography

  To perform a prospective clinical trial to quantitatively assess the effects of NanoSilk Cosmo solution on the skin surface topography using VISIA Gen 7. This device uses a non-invasive photograph and then through a series or different lighting on this photograph evaluates common skin surface topography concerns such as spots, pores, wrinkles, texture, porphyrins, UV spots, red areas, and brown spots.

  6 months

Study Arms (1)

NanoSilk Cosmo

EXPERIMENTAL

Participants will receive a 30 mL jar of NanoSilk Cosmo

Other: NanoSilk Cosmo

Interventions

NanoSilk Cosmo OTHER

Participant will receive 30 mL of NanoSilk Cosmo jar.

NanoSilk Cosmo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, female, and gender non-binary
• Age 18 years and older
• Any race or ethnicity
• Those with evidence of age-related skin changes.

You may not qualify if:

• \<18 years of age
• Pregnant
• Decisionally challenged

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Health and Wellness Center

Aurora, Colorado, 80045, United States

Location

Study Officials

• Brooke French, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 16, 2020
• Study Start: May 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)