Echographic Measurement of Skin Thickness

Echographic Measurement of Skin Thickness at the Deltoid and Proximal Forearm in Adults

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.

Study Overview

• Status: Completed
• Conditions: Skin Thickness
• Intervention / Treatment: Other: Echographic measurement of skin thickness

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Wilrijk, Antwerp, Belgium, 2610
      • Department of Pharmaceutical Sciences; Laboratory of Physiopharmacology; University of Antwerp; Campus Drie Eiken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• 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, in the period of January 2015 until April 2015.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants aged 18-30 years; 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	Other: Echographic measurement of skin thickness; (Epi)Dermal thickness at the proximal forearm and the deltoid region will be measured using imaging technology, more specifically high-frequency ultrasound (20-40 MHz) in B-mode (VEVO 2100®, 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 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 31-40 years; 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	Other: Echographic measurement of skin thickness; (Epi)Dermal thickness at the proximal forearm and the deltoid region will be measured using imaging technology, more specifically high-frequency ultrasound (20-40 MHz) in B-mode (VEVO 2100®, 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 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 41-50 years; 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	Other: Echographic measurement of skin thickness; (Epi)Dermal thickness at the proximal forearm and the deltoid region will be measured using imaging technology, more specifically high-frequency ultrasound (20-40 MHz) in B-mode (VEVO 2100®, 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 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 51-65 years; 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	Other: Echographic measurement of skin thickness; (Epi)Dermal thickness at the proximal forearm and the deltoid region will be measured using imaging technology, more specifically high-frequency ultrasound (20-40 MHz) in B-mode (VEVO 2100®, 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 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 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
skin thickness (in milimeters) of the deltoid region (both left and right)	10 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Novosanis NV
• Investigators: Principal Investigator: Vanessa Vankerckhoven, PhD, CEO

Publications and helpful links

General Publications

• Van Mulder TJ, de Koeijer M, Theeten H, Willems D, Van Damme P, Demolder M, De Meyer G, Beyers KC, Vankerckhoven V. High frequency ultrasound to assess skin thickness in healthy adults. Vaccine. 2017 Mar 27;35(14):1810-1815. doi: 10.1016/j.vaccine.2016.07.039. Epub 2016 Aug 3.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: February 4, 2015
• First Submitted That Met QC Criteria: February 9, 2015
• First Posted (Estimate): February 16, 2015

Study Record Updates

• Last Update Posted (Estimate): October 6, 2015
• Last Update Submitted That Met QC Criteria: October 5, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: skin thickness; high-frequency ultrasound
• Other Study ID Numbers: 300201523257