Echographic Measurement of Skin Thickness in Children

Skin Thickness Clinical Trial

— PIDIC-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727114
• Other study ID #: 2015_NOV_VX_003
• Status: Completed
• Phase: N/A
• First received: March 23, 2016
• Last updated: September 19, 2017
• Start date: February 2016
• Est. completion date: July 2017

Study information

• Verified date: September 2017
• Source: Novosanis NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Weeks to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Thickness

Intervention

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.

Locations

Country	Name	City	State
Belgium	Child & Family (Dutch: Kind&Gezin) Antwerp	Antwerp
Belgium	primary and secundary schools in Antwerp, Belgium	Antwerp
Belgium	University of Antwerp	Wilrijk	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Novosanis NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	skin thickness (in millimeters) of the proximal dorsal forearm (both left and right)		5-10 minutes
Primary	skin thickness (in millimeters) of the proximal ventral forearm (both left and right)		5-10 minutes
Primary	skin thickness (in millimeters) of the deltoid region (both left and right)		5-10 minutes
Primary	skin thickness (in millimeters) of the medial thigh region (both left and right)		5 minutes