Skin ThicknessPIDIC-1NCT02727114
Echographic Measurement of Skin Thickness in Children
An observational study of Skin Thickness, run by Novosanis NV at 3 sites 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 children (aged 8 weeks to 18 years) using imaging… Read more about this study
- Who is it for?
- Ages 8 weeks to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Thickness
- What is being tested?
- Echographic measurement of skin thickness
- How many people
- 259 participants
- Where
- 3 sitesBelgium
- Study dates
- Feb 2016to Jul 2017
- 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 8 weeks to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants will be recruited in the vicinity of the university and its university hospital of Antwerp. Through primary and secundary school in Antwerp, children will be recruited after approval of their parents and via some Child and Family (Dutch: Kind\&Gezin) facilities children aged 8 weeks to 3 years will recruited. All recruitement will be done from October 2015 until November 15th 2015.
Who may be able to join
- Healthy children
- Age: 8 weeks to 18 years
- Dutch-speaking
- Caucasian
Who cannot join
- Using ointment, crème, gels or oral medication based on corticoids
- Suffering from skin diseases (psoriasis, burning wounds)
- Pregnancy or lactating
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Child & Family (Dutch: Kind&Gezin) Antwerp
Antwerp, 2018
primary and secundary schools in Antwerp, Belgium
Antwerp
University of Antwerp
Wilrijk, Antwerp, 2610
About this study
Official title: Echographic Imaging Research to the Anatomical and Physiological Characteristics of the Skin in Children and Adolescents
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 children (aged 8 weeks to 18 years) 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, the deltoid region and medial site of the thigh (till 2 years) will be measured using imaging technology, more specifically high-frequency ultrasound (20-70 MHz) in B-mode (VEVO 2100® \& VEVO 3100®, 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 and medial thigh 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 8 weeks to 3 years | Echographic measurement of skin thickness at the proximal forearm, the deltoid region and medial thigh (till age of 2 years) in participants aged 8 weeks to 3 years.
aimed number: 32 boys \& 32 girls / maximum number: 50 boys \& 50 girls Receives: Other: Echographic measurement of skin thickness | |
| participants aged 3 to 6 years | Echographic measurement of skin thickness at the proximal forearm and the deltoid region in participants aged 3 to 6 years.
aimed number: 32 boys \& 32 girls / maximum number: 50 boys \& 50 girls Receives: Other: Echographic measurement of skin thickness | |
| participants aged 6 to 12 years | Echographic measurement of skin thickness at the proximal forearm and the deltoid region in participants aged 6 to 12 years.
aimed number: 32 boys \& 32 girls / maximum number: 50 boys \& 50 girls Receives: Other: Echographic measurement of skin thickness | |
| participants aged 12 to 18 years | Echographic measurement of skin thickness at the proximal forearm and the deltoid region in participants aged 12 to 18 years.
aimed number: 32 boys \& 32 girls / maximum number: 50 boys \& 50 girls 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 millimeters) of the proximal dorsal forearm (both left and right)
Measured: 5-10 minutes
skin thickness (in millimeters) of the proximal ventral forearm (both left and right)
Measured: 5-10 minutes
skin thickness (in millimeters) of the deltoid region (both left and right)
Measured: 5-10 minutes
skin thickness (in millimeters) of the medial thigh region (both left and right)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2017
- Study completionJul 2017
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
- 259 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
- NCT02727114
- Sponsor's protocol ID
- 2015_NOV_VX_003
- Acronym
- PIDIC-1
- Status last verified
- Sep 2017
- First submitted
- 23 Mar 2016
- Last updated
- 21 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Van Mulder TJS, Van Nuffel D, Demolder M, De Meyer G, Moens S, Beyers KCL, Vankerckhoven VVJ, Van Damme P, Theeten H. Skin thickness measurements for optimal intradermal injections in children. Vaccine. 2020 Jan 22;38(4):763-768. doi: 10.1016/j.vaccine.2019.11.002. Epub 2019 Nov 22.
PubMed 31767463
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echographic Imaging Research to the Anatomical and Physiological Characteristics of the Skin in Children and Adolescents
- ClinicalTrials.gov ID
- NCT02727114
- Acronym / sponsor ID
- PIDIC-1 / 2015_NOV_VX_003
- Conditions
- Skin Thickness
- Keywords
- skin thickness, high-frequency ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Novosanis NVIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 4 Apr 2016 (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 children (aged 8 weeks to 18 years) 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 8 weeks to 3 years | – | Other: Echographic measurement of skin thicknessEchographic measurement of skin thickness at the proximal forearm, the deltoid region and medial thigh (till age of 2 years) in participants aged 8 weeks to 3 years. aimed number: 32 boys \& 32 girls / maximum number: 50 boys \& 50 girls |
| participants aged 3 to 6 years | – | Other: Echographic measurement of skin thicknessEchographic measurement of skin thickness at the proximal forearm and the deltoid region in participants aged 3 to 6 years. aimed number: 32 boys \& 32 girls / maximum number: 50 boys \& 50 girls |
| participants aged 6 to 12 years | – | Other: Echographic measurement of skin thicknessEchographic measurement of skin thickness at the proximal forearm and the deltoid region in participants aged 6 to 12 years. aimed number: 32 boys \& 32 girls / maximum number: 50 boys \& 50 girls |
| participants aged 12 to 18 years | – | Other: Echographic measurement of skin thicknessEchographic measurement of skin thickness at the proximal forearm and the deltoid region in participants aged 12 to 18 years. aimed number: 32 boys \& 32 girls / maximum number: 50 boys \& 50 girls |
Who may qualify
- Ages
- 8 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants will be recruited in the vicinity of the university and its university hospital of Antwerp. Through primary and secundary school in Antwerp, children will be recruited after approval of their parents and via some Child and Family (Dutch: Kind\&Gezin) facilities children aged 8 weeks to 3 years will recruited. All recruitement will be done from October 2015 until November 15th 2015.
Key inclusion criteria (4 listed)
- Healthy children
- Age: 8 weeks to 18 years
- Dutch-speaking
- Caucasian
Key exclusion criteria (3 listed)
- Using ointment, crème, gels or oral medication based on corticoids
- Suffering from skin diseases (psoriasis, burning wounds)
- Pregnancy or lactating
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, the deltoid region and medial site of the thigh (till 2 years) will be measured using imaging technology, more specifically high-frequency ultrasound (20-70 MHz) in B-mode (VEVO 2100® \& VEVO 3100®, 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 and medial thigh 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 12 to 18 years, participants aged 3 to 6 years, participants aged 6 to 12 years, participants aged 8 weeks to 3 years |
Primary outcome
skin thickness (in millimeters) of the proximal dorsal forearm (both left and right)
Time frame: 5-10 minutes
skin thickness (in millimeters) of the proximal ventral forearm (both left and right)
Time frame: 5-10 minutes
skin thickness (in millimeters) of the deltoid region (both left and right)
Time frame: 5-10 minutes
skin thickness (in millimeters) of the medial thigh region (both left and right)
Time frame: 5 minutes
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 21 Sep 2017.
- Derived from this study: PubMed 31767463Van Mulder TJS, Van Nuffel D, Demolder M, De Meyer G, Moens S, Beyers KCL, Vankerckhoven VVJ, Van Damme P, Theeten H. Skin thickness measurements for optimal intradermal injections in children. Vaccine. 2020 Jan 22;38(4):763-768. doi: 10.1016/j.vaccine.2019.11.002. Epub 2019 Nov 22.
- Individual participant dataSharing planned: No
Related trials for Skin Thickness
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Recruiting
Surgical Outcomes of Simple Interrupted Versus Running Epidermal Sutures in Full-thickness Skin Graft Placement
Skin Graft Scar
Not yet recruiting
Full-Thickness Skin Graft Sizing and Scar Quality
Graft Healing
Not yet recruiting
Autologous Skin Cell Suspension (RECELL®) for Accelerated Healing of Split-Thickness Skin Graft Donor Sites: A Randomized, Intra-Patient (Split-Site) Controlled Trial
Skin Graft Donor Site, Wound Healing
Recruiting
Autologous Fat Grafting Beneath Penile Split Thickness Skin Graft Placement During Penile Reconstruction
Penis/Surgery, Penis/Injuries
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
3 sites 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 3 sites 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 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 millimeters) of the proximal dorsal forearm (both left and right) (time frame: 5-10 minutes). The study lists 4 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 NCT02727114, 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 21 Sep 2017.