Dermatologic DiseaseHLSkinPedNCT03578718
Evaluation of the Interest of a Specialist in Dermatology for Dermatopediatric Consultations
An observational study of Dermatologic Disease and Pediatric ALL, run by Central Hospital, Nancy, France.
Trial summary
Dermatologic diseases, of very different etiology and variable severity, represent a major motivation for consultation (in private consultations and in emergency departments), thus leading pediatricians to frequently turn to dermatologic advice. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Dermatologic Disease, Pediatric ALL, Collaboration
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2018to 1 May 2019
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: all patients Under 18 years old consulting for a dermatological problem in emergency department or in a private pediatric consultation
Who may be able to join
- Under 18 years old
- consultating for dermatologic problem in emergency department (1 department) or private pediatric center (1 center)
- signed consent
- consécutives consultations
Who cannot join
- no consent
Trial locations and contacts
No sites are listed yet.
About this study
Dermatologic diseases, of very different etiology and variable severity, represent a major motivation for consultation (in private consultations and in emergency departments), thus leading pediatricians to frequently turn to dermatologic advice.
The principal aim is to estimate the degree of concordance of the main diagnosis between a pediatrician and a pediatric dermatologist.
The secondary aims is to estimate the degree of concordance of the treatment, advices and follow-up.
- Conditions
- Dermatologic Disease, Pediatric ALL, Collaboration
- Medical subject headings
- Skin Diseases, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
principal diagnosis
% of concordance between diagnosis (dermatologist/pediatric)
Measured: baseline
Secondary outcomes (3)
treament
% of concordance between treatment (dermatologist/pediatric)
Measured: baseline
advices
% of concordance between advices(dermatologist/pediatric)
Measured: baseline
follow-up
% of concordance between follow-up (dermatologist/pediatric)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start25 Jun 2018 (estimated)
- Primary completion1 May 2019 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatologic DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578718
- Sponsor's protocol ID
- 2018-A00088-47
- Acronym
- HLSkinPed
- Status last verified
- Jun 2018
- First submitted
- 25 Jun 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Interest of a Specialist in Dermatology for Dermatopediatric Consultations
- ClinicalTrials.gov ID
- NCT03578718
- Acronym / sponsor ID
- HLSkinPed / 2018-A00088-47
- Conditions
- Dermatologic Disease, Pediatric ALL, Collaboration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 25 Jun 2018 (estimated)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 6 Jul 2018 (actual)
- 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.
Dermatologic diseases, of very different etiology and variable severity, represent a major motivation for consultation (in private consultations and in emergency departments), thus leading pediatricians to frequently turn to dermatologic advice.
The principal aim is to estimate the degree of concordance of the main diagnosis between a pediatrician and a pediatric dermatologist.
The secondary aims is to estimate the degree of concordance of the treatment, advices and follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- all patients Under 18 years old consulting for a dermatological problem in emergency department or in a private pediatric consultation
Key inclusion criteria (4 listed)
- Under 18 years old
- consultating for dermatologic problem in emergency department (1 department) or private pediatric center (1 center)
- signed consent
- consécutives consultations
Key exclusion criteria (1 listed)
- no consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
principal diagnosis
Time frame: baseline
% of concordance between diagnosis (dermatologist/pediatric)
3 secondary outcomes
treament
Time frame: baseline
advices
Time frame: baseline
follow-up
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatologic Disease and Pediatric ALL, run by Central Hospital, Nancy, France.
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 1 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: status not confirmed, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BURSZTEJN Anne Calire, MCU-PH (+3383157153, ac.bursztejn@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
principal diagnosis (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2018.