Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2015-01-31
2015-06-30
Brief Summary
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Based on these results, the investigators can define which needle type and length is needed to correctly perform injections into the dermal layer.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Participants aged 18-30 years
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
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.
Participants aged 31-40 years
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
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.
Participants aged 41-50 years
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
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.
Participants aged 51-65 years
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age: 18-65 years
* Dutch-speaking
* Caucasian
Exclusion Criteria
* Using ointment, crème, or gels based on corticoids
* Suffering from skin diseases (psoriasis, burning wounds)
18 Years
65 Years
ALL
Yes
Sponsors
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Novosanis NV
INDUSTRY
Responsible Party
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Principal Investigators
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Vanessa Vankerckhoven, PhD
Role: PRINCIPAL_INVESTIGATOR
CEO
Locations
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Department of Pharmaceutical Sciences; Laboratory of Physiopharmacology; University of Antwerp; Campus Drie Eiken
Wilrijk, Antwerp, Belgium
Countries
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References
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Van Mulder TJ, de Koeijer M, Theeten H, Willems D, Van Damme P, Demolder M, De Meyer G, Beyers KC, Vankerckhoven V. High frequency ultrasound to assess skin thickness in healthy adults. Vaccine. 2017 Mar 27;35(14):1810-1815. doi: 10.1016/j.vaccine.2016.07.039. Epub 2016 Aug 3.
Other Identifiers
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300201523257
Identifier Type: -
Identifier Source: org_study_id
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