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OpenTrials
Completed

NCT Number: NCT02363465

Echographic Measurement of Skin Thickness

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.

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Key information

Conditions

Skin Thickness

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pharmaceutical Sciences; Laboratory of Physiopharmacology; University of Antwerp; Campus Drie Eiken

Wilrijk, Antwerp, 2610, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Echographic measurement of skin thickness

Other

(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.

Primary outcomes

  1. skin thickness (in milimeters) of the proximal forearm dorsal (both left and right)

    Time frame: 10 minutes

  2. skin thickness (in milimeters) of the proximal forearm ventral (both left and right)

    Time frame: 10 minutes

  3. skin thickness (in milimeters) of the deltoid region (both left and right)

    Time frame: 10 minutes

Secondary outcomes

  1. Body Mass Index

    Time frame: at the moment of entering the study

  2. Age

    Time frame: at the moment of entering the study

  3. sex

    Time frame: at the moment of entering the study

Sponsors and collaborators

Lead sponsor

Novosanis NV

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 16, 2015
Registry last updated
Oct 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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