Echographic Measurement of Skin Thickness in Children

NCT02727114 | Completed

• 1 other identifier: 2015_NOV_VX_003
• Study Type: observational
• Target: 259
• Locations: 1 country
• Sites: 3

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

Conditions

Skin Thickness

Keywords

skin thickness; high-frequency ultrasound

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

participants aged 8 weeks to 3 years

Echographic measurement of skin thickness at the proximal forearm, the deltoid region and medial thigh (till age of 2 years) in participants aged 8 weeks to 3 years. aimed number: 32 boys \& 32 girls / maximum number: 50 boys \& 50 girls

Other: Echographic measurement of skin thickness

participants aged 3 to 6 years

Echographic measurement of skin thickness at the proximal forearm and the deltoid region in participants aged 3 to 6 years. aimed number: 32 boys \& 32 girls / maximum number: 50 boys \& 50 girls

Other: Echographic measurement of skin thickness

participants aged 6 to 12 years

Echographic measurement of skin thickness at the proximal forearm and the deltoid region in participants aged 6 to 12 years. aimed number: 32 boys \& 32 girls / maximum number: 50 boys \& 50 girls

Other: Echographic measurement of skin thickness

participants aged 12 to 18 years

Echographic measurement of skin thickness at the proximal forearm and the deltoid region in participants aged 12 to 18 years. aimed number: 32 boys \& 32 girls / maximum number: 50 boys \& 50 girls

Other: Echographic measurement of skin thickness

Interventions

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.

participants aged 12 to 18 years; participants aged 3 to 6 years; participants aged 6 to 12 years; participants aged 8 weeks to 3 years

Eligibility Criteria

• Age: 8 Weeks - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Novosanis NV: lead

Study Sites (3)

University of Antwerp

Wilrijk, Antwerp, 2610, Belgium

Location

Child & Family (Dutch: Kind&Gezin) Antwerp

Antwerp, 2018, Belgium

Location

primary and secundary schools in Antwerp, Belgium

Antwerp, Belgium

Location

Related Publications (1)

• 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.

  PMID: 31767463 DERIVED

Study Officials

• Vanessa Vankerckhoven, PhD

  CEO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 4, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 21, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)