NCT02363465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 16, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 6, 2015

Status Verified

October 1, 2015

Enrollment Period

5 months

First QC Date

February 4, 2015

Last Update Submit

October 5, 2015

Conditions

Skin Thickness

Keywords

skin thicknesshigh-frequency ultrasound

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • 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

Study Arms (4)

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

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

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

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

Interventions

Echographic measurement of skin thicknessOTHER

(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 18-30 yearsParticipants aged 31-40 yearsParticipants aged 41-50 yearsParticipants aged 51-65 years

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Wilrijk, Antwerp, 2610, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 27496276DERIVED

Study Officials

  • Vanessa Vankerckhoven, PhD

    CEO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 16, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

October 6, 2015

Record last verified: 2015-10

Locations

BE(1)