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OpenTrials
Completed

NCT Number: NCT02727114

Echographic Measurement of Skin Thickness in Children

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

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Key information

Conditions

Skin Thickness

Age range

8 week–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Antwerp, Wilrijk, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echographic measurement of skin thickness

Other

(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.

Primary outcomes

  1. skin thickness (in millimeters) of the proximal dorsal forearm (both left and right)

    Time frame: 5-10 minutes

  2. skin thickness (in millimeters) of the proximal ventral forearm (both left and right)

    Time frame: 5-10 minutes

  3. skin thickness (in millimeters) of the deltoid region (both left and right)

    Time frame: 5-10 minutes

  4. skin thickness (in millimeters) of the medial thigh region (both left and right)

    Time frame: 5 minutes

Sponsors and collaborators

Lead sponsor

Novosanis NV

Industry

Registry information

Official study title

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

Acronym: PIDIC-1

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 4, 2016
Registry last updated
Sep 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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