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Echographic Measurement of Skin Thickness

Echographic Measurement of Skin Thickness at the Deltoid and Proximal Forearm in Adults

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02363465
Enrollment
100
Registered
2015-02-16
Start date
2015-01-31
Completion date
2015-06-30
Last updated
2015-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Thickness

Keywords

skin thickness, high-frequency ultrasound

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.

Interventions

(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.

Sponsors

Novosanis NV
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy adults * Age: 18-65 years * Dutch-speaking * Caucasian

Exclusion criteria

* Pregnancy or lactating * Using ointment, crème, or gels based on corticoids * Suffering from skin diseases (psoriasis, burning wounds)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Body Mass Indexat the moment of entering the study
Ageat the moment of entering the study
sexat the moment of entering the study

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026