Echographic Measurement of Skin Thickness

Completed

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

• Registration Number: NCT02363465
• 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 adults 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: 2015-01
• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-02-09
• Study First Posted: 2015-02-16
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Healthy adults
• Age: 18-65 years
• Dutch-speaking
• Caucasian

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants aged 18-30 years	Echographic measurement of skin thickness	Echographic measurement of skin thickness at the proximal forearm and the deltoid region in participants aged 18-30 years. aimed number: 12 male \& 12 female maximum number: 15 male \& 15 female
Participants aged 31-40 years	Echographic measurement of skin thickness	Echographic measurement of skin thickness at the proximal forearm and the deltoid region in participants aged 31-40 years. aimed number: 12 male \& 12 female maximum number: 15 male \& 15 female
Participants aged 41-50 years	Echographic measurement of skin thickness	Echographic measurement of skin thickness at the proximal forearm and the deltoid region in participants aged 41-50 years. aimed number: 12 male \& 12 female maximum number: 15 male \& 15 female
Participants aged 51-65 years	Echographic measurement of skin thickness	Echographic measurement of skin thickness at the proximal forearm and the deltoid region in participants aged 51-65 years. aimed number: 12 male \& 12 female maximum number: 15 male \& 15 female

Primary Outcome Measures

Name	Time	Method
skin thickness (in milimeters) of the deltoid region (both left and right)	10 minutes
skin thickness (in milimeters) of the proximal forearm dorsal (both left and right)	10 minutes
skin thickness (in milimeters) of the proximal forearm ventral (both left and right)	10 minutes

Secondary Outcome Measures

Name	Time	Method
Body Mass Index	at the moment of entering the study
Age	at the moment of entering the study
sex	at the moment of entering the study

Trial Locations

Locations (1)

Department of Pharmaceutical Sciences; Laboratory of Physiopharmacology; University of Antwerp; Campus Drie Eiken; 🇧🇪 Wilrijk, Antwerp, Belgium