Echographic Measurement of Skin Thickness in Children

Completed

• Conditions: Skin Thickness
• Interventions: Other: Echographic measurement of skin thickness

• Registration Number: NCT02727114
• Lead Sponsor: Novosanis NV

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-03-23
• Study First Submitted QC: 2016-03-29
• Study First Posted: 2016-04-04
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-19
• Last Update Posted: 2017-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 259

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
participants aged 8 weeks to 3 years	Echographic measurement of skin thickness	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
participants aged 6 to 12 years	Echographic measurement of skin thickness	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
participants aged 3 to 6 years	Echographic measurement of skin thickness	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
participants aged 12 to 18 years	Echographic measurement of skin thickness	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

Primary Outcome Measures

Name	Time	Method
skin thickness (in millimeters) of the deltoid region (both left and right)	5-10 minutes
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 medial thigh region (both left and right)	5 minutes

Trial Locations

Locations (3)

University of Antwerp; 🇧🇪 Wilrijk, Antwerp, Belgium

Child & Family (Dutch: Kind&Gezin) Antwerp; 🇧🇪 Antwerp, Belgium

primary and secundary schools in Antwerp, Belgium; 🇧🇪 Antwerp, Belgium