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Echographic Measurement of Skin Thickness in Children

Echographic Imaging Research to the Anatomical and Physiological Characteristics of the Skin in Children and Adolescents

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02727114
Acronym
PIDIC-1
Enrollment
259
Registered
2016-04-04
Start date
2016-02-29
Completion date
2017-07-31
Last updated
2017-09-21

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 children (aged 8 weeks to 18 years) 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, the deltoid region and medial site of the thigh (till 2 years) will be measured using imaging technology, more specifically high-frequency ultrasound (20-70 MHz) in B-mode (VEVO 2100® & VEVO 3100®, 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 and medial thigh 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
8 Weeks to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy children * Age: 8 weeks to 18 years * Dutch-speaking * Caucasian

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
skin thickness (in millimeters) of the proximal dorsal forearm (both left and right)5-10 minutes
skin thickness (in millimeters) of the proximal ventral forearm (both left and right)5-10 minutes
skin thickness (in millimeters) of the deltoid region (both left and right)5-10 minutes
skin thickness (in millimeters) of the medial thigh region (both left and right)5 minutes

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026