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NCT04630418 · ClinicalTrials.gov registry record · NA
NanoSilk Cosmo: Evaluation of a Novel Silk Complex on Biophysical Parameters Related to Skin Aging
A NA study of Aging, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT04630418: Completed NA study of Aging, sponsored by University of Colorado, Denver.
NCT04630418 is a NA study of Aging that has completed, run by University of Colorado, Denver. The registered enrollment target is 46 participants, below the 2,195-participant average among 262 other Aging trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04630418, a NA study of Aging, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
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).
Primary Outcome
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
Conditions Studied
Interventions
- OTHER NanoSilk Cosmo
Study Locations (1)
Colorado
- University of Colorado Anschutz Health and Wellness Center - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2021-05-01 |
| Est. Completion | 2022-01-01 |
| Phase | NA |
What the finished NCT04630418 record still lists
NCT04630418 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 2,195-participant average among 262 other Aging trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Aging appearing as the primary indexed condition, and to 1 intervention - of which NanoSilk Cosmo is the first listed.
NCT04630418 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT04630418 about?
NCT04630418 is a clinical study titled "NanoSilk Cosmo: Evaluation of a Novel Silk Complex on Biophysical Parameters Related to Skin Aging". 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 ha...
What is the current status of trial NCT04630418?
This trial is currently completed. It is a NA study. The enrollment target is 46 participants. The study started on 2021-05-01. Estimated completion is 2022-01-01.
What conditions does trial NCT04630418 study?
This clinical trial studies the following conditions: Aging.
What interventions are being tested in trial NCT04630418?
The interventions under investigation include: NanoSilk Cosmo (OTHER).
Who is sponsoring clinical trial NCT04630418?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04630418 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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46 161st of 262 higher than 98 of 262 other Aging trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aging trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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