Echographic Measurement of Skin Thickness

Skin Thickness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02363465
• Other study ID #: 300201523257
• Status: Completed
• Phase: N/A
• First received: February 4, 2015
• Last updated: October 5, 2015
• Start date: January 2015
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Novosanis NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Skin Thickness

Intervention

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.

Locations

Country	Name	City	State
Belgium	Department of Pharmaceutical Sciences; Laboratory of Physiopharmacology; University of Antwerp; Campus Drie Eiken	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 milimeters) of the proximal forearm dorsal (both left and right)		10 minutes	No
Primary	skin thickness (in milimeters) of the proximal forearm ventral (both left and right)		10 minutes	No
Primary	skin thickness (in milimeters) of the deltoid region (both left and right)		10 minutes	No
Secondary	Body Mass Index		at the moment of entering the study	No
Secondary	Age		at the moment of entering the study	No
Secondary	sex		at the moment of entering the study	No