Atopic DermatitisPRURINEONCT03684343
Comparative Analysis of Filmed Sequences for the Assessment of Discomfort in Atopic Dermatitis of Infants Under 6 Months of Age
A study testing Filmed consultation with a dermatologist in people with Atopic Dermatitis, run by University Hospital, Brest at 1 site in France.
Trial summary
Atopic dermatitis (AD) is an frequent chronic and itchy inflammatory dermatitis which concern about 20% of pediatric population with a revelation usually toward 3-6 months of live. However, there are very few data about the prevalence of pruritus of young infants and about the discomfort linked with it. Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Filmed consultation with a dermatologist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2020to 15 Oct 2021
- Phase
- Interventional
- 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 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Young infant Under 6 month
- Patient with AD (SCORAD between 25 and 50 for moderate AD and > 50 for severe AD)
- Informed consent of the patient's parents
- Healthy patients :
- Young infant under 6 month
- Free of any pathology
- Informed consent of the patient's parents
Who cannot join
- Acute intercurrent disease
- Severe malformation
- Underage parents or parent unable to give their consent
Trial locations and contacts
1 site in 1 country.
About this study
Atopic dermatitis (AD) is an frequent chronic and itchy inflammatory dermatitis which concern about 20% of pediatric population with a revelation usually toward 3-6 months of live. However, there are very few data about the prevalence of pruritus of young infants and about the discomfort linked with it. While the skin and the nervous system of young infants (Under 6 month) are competent in pruritus experiment, the acquisition of conscious and deliberate motor ability allowing specific scratching of the body parts which are affected is possible only from 6 month. Thus, the diagnosis of AD intensity and the assesment of the potential associated discomfort are hard. At the present time, the diagnosis and the assesment of pruritus of children are based on a hetero-assesment via scales which are not applicable for infants under 6 month. The visual scale "Numeric Rating Scale" validated in adult population seems to be the most specific to assess AD severity. In pediatric population, the use of "Eppendorf Itch Questionnaire" and the american version of "Childhood Atopic Dermatitis Impact Scale" are recommended. Alternatives to clinic and subjective scoring of pruritus severity are described via actigraphy. Thus, a strong statistic correlation have been demonstrated between a nocturne measure of motor activity of wrist, as a reflect of the intensity of pruritus, and infra-red video analysis. But, once again, the technic is not adapted to young infants because of the absence of conscious and oriented motor ability and as a result of less organised sleep/wake cycle.
In order to improve young infants' (Under 6 month) care, the analysis of their behaviours with AD seems to be necessary to better identify a discomfort of these patients.
- Conditions
- Atopic Dermatitis
- Being tested
- Filmed consultation with a dermatologist
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filmed consultation with a dermatologistOther
Patient will be seen by a dermatologist for a consultation which will be filmed. During the consult, a laterality test and a tactile sensitivity test will be performed.
After the consult, videos will be analysed by scientists to identify the frequency of occurrence of each behavior and the percentage of time passed to express each behavior.
| Study group | Role | What they receive |
|---|---|---|
| Atopic Dermatitis patients | Other | Filmed consultation with a dermatologist. Laterality and tactile sensitivity test. Receives: Other: Filmed consultation with a dermatologist |
| Healthy patients | Other | Filmed consultation with a dermatologist. Laterality and tactile sensitivity test. Receives: Other: Filmed consultation with a dermatologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of occurrence of each behaviors
The frequency of occurrence of each behaviors will be identify.
Measured: Day 0
Percentage of time passed to express each behavior
The percentage of time passed to express each behavior will be noted.
Measured: Day 0
Secondary outcomes (3)
SCORin Atopic Dermatitis
SCORAD is a severity score used for atopic dermatitis. Only patients with AD will performed this test. SCORAD<25 : mild AD; 25<SCORAD<50 : moderate AD and SCORAD >50 : severe AD
Measured: Day 0
Tactile sensitivity test
Von frey filaments will be applied on the patients skin to estimate the reaction threshold to a subtle tactile stimuli.
Measured: Day 0
Laterality test
An object will be presented to the patient and the dermatologist will note the hand used by the patient to take it.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start13 Jan 2020
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Why it stopped: inclusion difficulties
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 Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684343
- Sponsor's protocol ID
- 29BRC17.0205 - PRURINEO
- Acronym
- PRURINEO
- Status last verified
- Jan 2023
- First submitted
- 11 Sep 2018
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boyard A, Cosnard C, Simon D, Le Pors C, Abasq-Thomas C, Grandgeorge M, Misery L, Henry S, Roue JM. Evidences for gestures associated with pruritus in very young infants: a pilot study. Sci Rep. 2025 Apr 8;15(1):11943. doi: 10.1038/s41598-025-93412-8.
PubMed 40199912
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Filmed Sequences for the Assessment of Discomfort in Atopic Dermatitis of Infants Under 6 Months of Age
- ClinicalTrials.gov ID
- NCT03684343
- Acronym / sponsor ID
- PRURINEO / 29BRC17.0205 - PRURINEO
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inclusion difficulties
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 25 Sep 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.
Atopic dermatitis (AD) is an frequent chronic and itchy inflammatory dermatitis which concern about 20% of pediatric population with a revelation usually toward 3-6 months of live. However, there are very few data about the prevalence of pruritus of young infants and about the discomfort linked with it. While the skin and the nervous system of young infants (Under 6 month) are competent in pruritus experiment, the acquisition of conscious and deliberate motor ability allowing specific scratching of the body parts which are affected is possible only from 6 month. Thus, the diagnosis of AD intensity and the assesment of the potential associated discomfort are hard. At the present time, the diagnosis and the assesment of pruritus of children are based on a hetero-assesment via scales which are not applicable for infants under 6 month. The visual scale "Numeric Rating Scale" validated in adult population seems to be the most specific to assess AD severity. In pediatric population, the use of "Eppendorf Itch Questionnaire" and the american version of "Childhood Atopic Dermatitis Impact Scale" are recommended. Alternatives to clinic and subjective scoring of pruritus severity are described via actigraphy. Thus, a strong statistic correlation have been demonstrated between a nocturne measure of motor activity of wrist, as a reflect of the intensity of pruritus, and infra-red video analysis. But, once again, the technic is not adapted to young infants because of the absence of conscious and oriented motor ability and as a result of less organised sleep/wake cycle.
In order to improve young infants' (Under 6 month) care, the analysis of their behaviours with AD seems to be necessary to better identify a discomfort of these patients.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atopic Dermatitis patients | Other | Other: Filmed consultation with a dermatologistFilmed consultation with a dermatologist. Laterality and tactile sensitivity test. |
| Healthy patients | Other | Other: Filmed consultation with a dermatologistFilmed consultation with a dermatologist. Laterality and tactile sensitivity test. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Young infant Under 6 month
- Patient with AD (SCORAD between 25 and 50 for moderate AD and > 50 for severe AD)
- Informed consent of the patient's parents
- Young infant under 6 month
- Free of any pathology
Key exclusion criteria (3 listed)
- Acute intercurrent disease
- Severe malformation
- Underage parents or parent unable to give their consent
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 |
|---|---|---|
| Filmed consultation with a dermatologistPatient will be seen by a dermatologist for a consultation which will be filmed. During the consult, a laterality test and a tactile sensitivity test will be performed. After the consult, videos will be analysed by scientists to identify the frequency of occurrence of each behavior and the percentage of time passed to express each behavior. | Other | Atopic Dermatitis patients, Healthy patients |
Primary outcome
Frequency of occurrence of each behaviors
Time frame: Day 0
The frequency of occurrence of each behaviors will be identify.
Percentage of time passed to express each behavior
Time frame: Day 0
The percentage of time passed to express each behavior will be noted.
3 secondary outcomes
SCORin Atopic Dermatitis
Time frame: Day 0
Tactile sensitivity test
Time frame: Day 0
Laterality test
Time frame: Day 0
Results and safety
The study was stopped early (reason given: inclusion difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Results publication: PubMed 40199912Boyard A, Cosnard C, Simon D, Le Pors C, Abasq-Thomas C, Grandgeorge M, Misery L, Henry S, Roue JM. Evidences for gestures associated with pruritus in very young infants: a pilot study. Sci Rep. 2025 Apr 8;15(1):11943. doi: 10.1038/s41598-025-93412-8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Filmed consultation with a dermatologist in people with Atopic Dermatitis, run by University Hospital, Brest at 1 site in 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 7 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: stopped early, as of the sponsor's last update on 12 Dec 2025. 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 France. 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 was stopped early (reason given: inclusion difficulties). Results are not available in the source record.
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?
Frequency of occurrence of each behaviors (time frame: Day 0). The study lists 2 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 NCT03684343, 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 12 Dec 2025.