Clinical trial NCT02727114: Echographic Measurement of Skin Thickness in Children
Official title: Echographic Imaging Research to the Anatomical and Physiological Characteristics of the Skin in Children and Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Thickness
Keywords: skin thickness
high-frequency ultrasound
Lead sponsor: Novosanis NV
Sponsor class: INDUSTRY
First posted: 2016-04-04
Enrollment: 259
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited in the vicinity of the university and its university hospital of Antwerp. Through primary and secundary school in Antwerp, children will be recruited after approval of their parents and via some Child and Family (Dutch: Kind\&Gezin) facilities children aged 8 weeks to 3 years will recruited.

All recruitement will be done from October 2015 until November 15th 2015.

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


Eligibility criteria: 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

Primary outcomes:
measure: skin thickness (in millimeters) of the proximal dorsal forearm (both left and right)
timeFrame: 5-10 minutes
measure: skin thickness (in millimeters) of the proximal ventral forearm (both left and right)
timeFrame: 5-10 minutes
measure: skin thickness (in millimeters) of the deltoid region (both left and right)
timeFrame: 5-10 minutes
measure: skin thickness (in millimeters) of the medial thigh region (both left and right)
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: University of Antwerp
state: Antwerp
city: Antwerp
country: Belgium
facility: Child & Family (Dutch: Kind&Gezin) Antwerp
city: Antwerp
country: Belgium
facility: primary and secundary schools in Antwerp, Belgium
Study officials:
affiliation: CEO
name: Vanessa Vankerckhoven, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Mulder TJS, Van Nuffel D, Demolder M, De Meyer G, Moens S, Beyers KCL, Vankerckhoven VVJ, Van Damme P, Theeten H. Skin thickness measurements for optimal intradermal injections in children. Vaccine. 2020 Jan 22;38(4):763-768. doi: 10.1016/j.vaccine.2019.11.002. Epub 2019 Nov 22.