An observational study in Skin Thickness, sponsored by Novosanis NV. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-06.
Sponsored by Novosanis NV · Observational
To optimize a medical device for intradermal injection, knowledge concerning the thickness of epidermis and dermis at the proximal forearm is required. Since scientific knowledge is lacking, the investigators will examine the skin thickness (epidermis and dermis) of adults using imaging technology (High Frequency Ultrasound). The investigators hypothesize that they are able to correlate the thickness of the (epi)dermis to a specific combination of parameters age, gender, and BMI.
Based on these results, the investigators can define which needle type and length is needed to correctly perform injections into the dermal layer.
Novosanis NV is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants will be recruited in the vicinity of the university and its university hospital of Antwerp, in the period of January 2015 until April 2015.
Exclusion Criteria:
Echographic measurement of skin thickness at the proximal forearm and the deltoid region in participants aged 18-30 years. aimed number: 12 male \& 12 female maximum number: 15 male \& 15 female
Other: Echographic measurement of skin thickness
Echographic measurement of skin thickness at the proximal forearm and the deltoid region in participants aged 31-40 years. aimed number: 12 male \& 12 female maximum number: 15 male \& 15 female
Other: Echographic measurement of skin thickness
Echographic measurement of skin thickness at the proximal forearm and the deltoid region in participants aged 41-50 years. aimed number: 12 male \& 12 female maximum number: 15 male \& 15 female
Other: Echographic measurement of skin thickness
Echographic measurement of skin thickness at the proximal forearm and the deltoid region in participants aged 51-65 years. aimed number: 12 male \& 12 female maximum number: 15 male \& 15 female
Other: Echographic measurement of skin thickness
(Epi)Dermal thickness at the proximal forearm and the deltoid region will be measured using imaging technology, more specifically high-frequency ultrasound (20-40 MHz) in B-mode (VEVO 2100®, Visual Sonics). This non-invasive measuring technique has already been proven to be accurate. The echographic measurement will be performed on the left and right deltoid region and on two sides of the proximal forearm. Both the dorsal part and the volar/palmar part of the proximal forearm will be investigated. Ultrasound will be executed using gel (Aquasonic®) to optimize imaging.
skin thickness (in milimeters) of the proximal forearm dorsal (both left and right)
Time frame: 10 minutes
skin thickness (in milimeters) of the proximal forearm ventral (both left and right)
Time frame: 10 minutes
skin thickness (in milimeters) of the deltoid region (both left and right)
Time frame: 10 minutes
Body Mass Index
Time frame: at the moment of entering the study
Age
Time frame: at the moment of entering the study
sex
Time frame: at the moment of entering the study
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Novosanis NV