Echographic Measurement of Skin Thickness

NCT ID: NCT02363465

Last Updated: 2015-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Skin Thickness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

Echographic measurement of skin thickness

Intervention Type 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.

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

Echographic measurement of skin thickness

Intervention Type 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.

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

Echographic measurement of skin thickness

Intervention Type 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.

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

Echographic measurement of skin thickness

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novosanis NV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vanessa Vankerckhoven, PhD

Role: PRINCIPAL_INVESTIGATOR

CEO

Locations

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

Wilrijk, Antwerp, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 27496276 (View on PubMed)

Other Identifiers

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300201523257

Identifier Type: -

Identifier Source: org_study_id

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