Skin ThicknessNCT02363465
Echographic Measurement of Skin Thickness
An observational study of Skin Thickness, run by Novosanis NV at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Thickness
- What is being tested?
- Echographic measurement of skin thickness
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2015to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Healthy adults
- Age: 18-65 years
- Dutch-speaking
- Caucasian
Who cannot join
- Pregnancy or lactating
- Using ointment, crème, or gels based on corticoids
- Suffering from skin diseases (psoriasis, burning wounds)
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Department of Pharmaceutical Sciences; Laboratory of Physiopharmacology; University of Antwerp; Campus Drie Eiken
Wilrijk, Antwerp, 2610
About this study
Official title: 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.
- Conditions
- Skin Thickness
- Being tested
- Echographic measurement of skin thickness
- Keywords
- skin thickness, high-frequency ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Echographic measurement of skin thickness |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin thickness (in milimeters) of the proximal forearm dorsal (both left and right)
Measured: 10 minutes
skin thickness (in milimeters) of the proximal forearm ventral (both left and right)
Measured: 10 minutes
skin thickness (in milimeters) of the deltoid region (both left and right)
Measured: 10 minutes
Secondary outcomes (3)
Body Mass Index
Measured: at the moment of entering the study
Age
Measured: at the moment of entering the study
sex
Measured: at the moment of entering the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin ThicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novosanis NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vanessa Vankerckhoven, PhD, Principal investigator, CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363465
- Sponsor's protocol ID
- 300201523257
- Status last verified
- Oct 2015
- First submitted
- 4 Feb 2015
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 27496276
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echographic Measurement of Skin Thickness at the Deltoid and Proximal Forearm in Adults
- ClinicalTrials.gov ID
- NCT02363465
- Acronym / sponsor ID
- 300201523257
- Conditions
- Skin Thickness
- Keywords
- skin thickness, high-frequency ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Novosanis NVIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Participants aged 18-30 years | – | Other: Echographic measurement of skin thicknessEchographic 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 |
| Participants aged 31-40 years | – | Other: Echographic measurement of skin thicknessEchographic 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 |
| Participants aged 41-50 years | – | Other: Echographic measurement of skin thicknessEchographic 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 |
| Participants aged 51-65 years | – | Other: Echographic measurement of skin thicknessEchographic 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Healthy adults
- Age: 18-65 years
- Dutch-speaking
- Caucasian
Key exclusion criteria (3 listed)
- Pregnancy or lactating
- Using ointment, crème, or gels based on corticoids
- Suffering from skin diseases (psoriasis, burning wounds)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Participants aged 18-30 years, Participants aged 31-40 years, Participants aged 41-50 years, Participants aged 51-65 years |
Primary outcome
skin thickness (in milimeters) of the proximal forearm dorsal (both left and right)
Time frame: 10 minutes
skin thickness (in milimeters) of the proximal forearm ventral (both left and right)
Time frame: 10 minutes
skin thickness (in milimeters) of the deltoid region (both left and right)
Time frame: 10 minutes
3 secondary outcomes
Body Mass Index
Time frame: at the moment of entering the study
Age
Time frame: at the moment of entering the study
sex
Time frame: at the moment of entering the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
- Derived from this study: PubMed 27496276Van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Vankerckhoven, PhD principal investigator
CEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Thickness, run by Novosanis NV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin thickness (in milimeters) of the proximal forearm dorsal (both left and right) (time frame: 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02363465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2015.