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

NCT04630418 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-12-14

No results posted yet for this study

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

Interventions

OTHER

NanoSilk Cosmo

Participant will receive 30 mL of NanoSilk Cosmo jar.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Brooke French, MD · University of Colorado, Denver

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2022-01-01
Completion
2022-01-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04630418 on ClinicalTrials.gov