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

Novosanis

Status: Completed

Conditions: Skin Thickness

Treatments: Other: Echographic measurement of skin thickness

Study type: Observational

Funder types: Industry

Identifiers

NCT02727114

2015_NOV_VX_003

Details and patient eligibility

About

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

Enrollment: 259 patients

Sex: All

Ages: 8 weeks to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

259 participants in 4 patient groups

participants aged 8 weeks to 3 years

Description:

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

Treatment:

Other: Echographic measurement of skin thickness

participants aged 3 to 6 years

Description:

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

Treatment:

Other: Echographic measurement of skin thickness

participants aged 6 to 12 years

Description:

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

Treatment:

Other: Echographic measurement of skin thickness

participants aged 12 to 18 years

Description:

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

Treatment:

Other: Echographic measurement of skin thickness