Echographic Measurement of Skin Thickness in Children (PIDIC-1)

September 19, 2017 updated by: Novosanis NV

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

259

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2018
        • Child & Family (Dutch: Kind&Gezin) Antwerp
      • Antwerp, Belgium
        • primary and secundary schools in Antwerp, Belgium
    • Antwerp
      • Wilrijk, Antwerp, Belgium, 2610
        • University of Antwerp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

(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 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

(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 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

(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

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

(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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
skin thickness (in millimeters) of the proximal dorsal forearm (both left and right)
Time Frame: 5-10 minutes
5-10 minutes
skin thickness (in millimeters) of the proximal ventral forearm (both left and right)
Time Frame: 5-10 minutes
5-10 minutes
skin thickness (in millimeters) of the deltoid region (both left and right)
Time Frame: 5-10 minutes
5-10 minutes
skin thickness (in millimeters) of the medial thigh region (both left and right)
Time Frame: 5 minutes
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novosanis NV

Investigators

  • Principal Investigator: Vanessa Vankerckhoven, PhD, CEO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

March 23, 2016

First Submitted That Met QC Criteria

March 29, 2016

First Posted (Estimate)

April 4, 2016

Study Record Updates

Last Update Posted (Actual)

September 21, 2017

Last Update Submitted That Met QC Criteria

September 19, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2015_NOV_VX_003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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