Echographic Measurement of Skin Thickness
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
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.
|
| 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 |
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.
|
| 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 |
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.
|
| 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 |
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.
|
Outcome Measures
Primary Outcome Measures
- skin thickness (in milimeters) of the proximal forearm dorsal (both left and right) [10 minutes]
- skin thickness (in milimeters) of the proximal forearm ventral (both left and right) [10 minutes]
- skin thickness (in milimeters) of the deltoid region (both left and right) [10 minutes]
Secondary Outcome Measures
- Body Mass Index [at the moment of entering the study]
- Age [at the moment of entering the study]
- sex [at the moment of entering the study]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy adults
-
Age: 18-65 years
-
Dutch-speaking
-
Caucasian
Exclusion Criteria:
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Pregnancy or lactating
-
Using ointment, crème, or gels based on corticoids
-
Suffering from skin diseases (psoriasis, burning wounds)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Pharmaceutical Sciences; Laboratory of Physiopharmacology; University of Antwerp; Campus Drie Eiken | Wilrijk | Antwerp | Belgium | 2610 |
Sponsors and Collaborators
- Novosanis NV
Investigators
- Principal Investigator: Vanessa Vankerckhoven, PhD, CEO
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 300201523257