Cutis Clinical Research Center
Kopavogur, Iceland
NCT Number: NCT03901846
The objective of this investigation is to verify that ColdZyme® is deposited onto the throat and estimate the half-life of the ColdZyme® solution in the oropharynx of human volunteers using a log-linear mixed-effects model (LMM).
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Kopavogur, Iceland
The study is an Open Label, Non-Comparative study intended to verify the method used to measure the duration of ColdZyme®. Each participant will be his own control as samples are taken before application of ColdZyme and used as an internal control. Samples will be taken from the oropharyngeal membrane using a cotton swab before application, and 1, 3, 5, 10, 20, and 60 minutes after application. Glycerol will then be extracted from the swabs using water and the concentration of glycerol will be measured.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ColdZyme is a Class I medical device (CE-marked) with the following composition: glycerol, water, Tris buffer, CaCl2, menthol and trypsin
Time frame: 0-60 minutes
To measure the duration of the ColdZyme barrier following intra-oral deposition, by analyzing the oro-pharyngeal glycerol amount over time between 0 and 60 minutes after application.
Enzymatica AB
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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