Atopic DermatitisNCT04553224
Collection of Clinical and Instrumental Data in Adult Subjects Suffering From Atopic Dermatitis
A study testing Clinical evaluations, Non-invasive instrumental measurements and Subject's evaluations in people with Atopic Dermatitis, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
Trial summary
Atopic dermatitis represents a real challenge in public health as it affects a large percentage of children and adults. Affected individuals must cope with a significant psychosocial burden, in addition to dealing with the medical aspects of the disease. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Clinical evaluations, Non-invasive instrumental measurements and Subject's evaluations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 12 Nov 2019to 10 Feb 2020
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject suffering from Atopic Dermatitis according to the U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis (3).
- Subject with mild to moderate Atopic Dermatitis with 20 <= SCORAD <= 40 at inclusion
- Subject with flare frequency ≥ 4 over the last year
- Subject with a cutaneous target area, allowing the measurements, located on upper or lower limbs and defined as a usual AD flare area according to the subject
- Subject owning a smartphone suitable with the 5.0 downloaded version of PO-Scorad® app
- Subject who agrees to use daily a free mobile app: PO-Scorad®
Who cannot join
- Subject having received artificial UV exposure or excessive exposure to natural sunlight within the 2 weeks before the inclusion visit or planning to be exposed to excessive or prolonged natural sunlight or UV exposures for the duration of the study
- Subject with a hirsute target area
- Systemic immunosuppressive therapy (excepted systemic corticoids) within 3 months before the inclusion visit or ongoing at inclusion visit.
- Systemic corticoids taken (whatever the number of intake) within 4 weeks before the inclusion visit or ongoing at inclusion visit.
- Phototherapy performed within 4 weeks before the inclusion visit or ongoing at inclusion visit
- Systemic antibiotics taken within 7 days before the inclusion visit or ongoing at inclusion visit.
Show all 10Show fewer
- Moderate to high-potency topical corticosteroids applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit
- Topical immunomodulators (TIMs), applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit
- Any topical treatment or product applied between the evening before the inclusion visit and the inclusion visit
- Water applied on target area within 4 hours before the inclusion visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collection of Clinical and Biometrological Data in Adult Subjects Suffering From Atopic Dermatitis (AD) During a Three-month Period
Atopic dermatitis represents a real challenge in public health as it affects a large percentage of children and adults. Affected individuals must cope with a significant psychosocial burden, in addition to dealing with the medical aspects of the disease.
The purpose of this exploratory study is to collect clinical severity AD data, using PO-SCORAD (self-assessment by the subjects), SCORAD evolution, instrumental measurements and treatment follow up of subjects.
The future objective is to develop a personalised prediction model of AD flares in order to improve management of AD by more accurate severity evaluations by the subject and the physician. Development of a method of early detection of flares will open new treatment pathways for AD management.
Read the detailed description
This study will be conducted as a French monocentric exploratory study in adults with mild to moderate Atopic Dermatitis, and will be conducted on a maximum 25 included subjects.
The clinical study will include 4 study visits, after inclusion visit, and the maximum duration of the study for each subject will be 3 months : Day 1, Day 29, Day 57, Day 85.
In case of AD flare suspicion, the investigator may recommend a complementary visit. Any complementary visit will be confirmed by investigator according to the subject's information: photographs and PO-SCORAD sent by the subject. If visit is confirmed, it will be scheduled as soon as possible.
The objectives are:
- to collect clinical AD severity data in order to evaluate natural AD evolution with clinical and subject's scales, during a three-month period.
- to collect non-invasive instrumental AD data on a target area and on adjacent area: cutaneous hydration, epidermal barrier conditions and colorimetric parameters on cutaneous erythema
- to examine clinical and instrumental AD data
- to collect illustrative photographs of AD lesions
- Conditions
- Atopic Dermatitis
- Being tested
- Clinical evaluations, Non-invasive instrumental measurements, Subject's evaluations
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical evaluationsOther
SCORAD and target SCORAD
Non-invasive instrumental measurementsOther
TEWL, cutaneous hydration, skin lipidic analysis, colorimetry, hydration index
Subject's evaluationsOther
PO-SCORAD, target PO-SCORAD and subject's questionnaire
| Study group | Role | What they receive |
|---|---|---|
| All Subjects | Other | Clinical and instrumental measurements Receives: Other: Clinical evaluations; Other: Non-invasive instrumental measurements; Other: Subject's evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on clinical evaluation (investigator evaluation) : SCORAD
The SCORAD is a scoring system based on the assessment of extent and intensity in a standardized manner
Measured: Day1, Day29, Day57 and Day85
Change on clinical evaluation (investigator evaluation) : Target SCORAD
Target SCORAD is the sum of all SCORAD objective signs scores: erythema, oedema/papulation, oozing/crusts, excoriation, lichenification and dryness evaluated on a target area
Measured: Day1, Day29, Day57 and Day85
Change on instrumental measurement performed by investigational team : TEWL
TEWL: Transepidermal water loss. TEWL tracks the passage of water through the skin
Measured: Day1, Day29, Day57 and Day85
Change on instrumental measurement performed by investigational team : Lipidic analysis
The proportion of lipids will be analysed on specific bands of infrared spectra by calculation of area under curve of the peaks
Measured: Day1, Day29, Day57 and Day85
Change on instrumental measurement performed by investigational team : cutaneous hydration
Cutaneous hydration evaluated by humidity of the stratum corneum. The measurement is based on capacitance measurement of the stratum corneum.
Measured: Day1, Day29, Day57 and Day85
Change on instrumental measurement performed by investigational team : colorimetric parameter of cutaneous erythema
Evaluation with objective assessment the color of the surface of the skin. Data output will be in the form of the L* a* b* color coordinate system. The a* values (red/ green) will be assessed for quantifying the degree of erythema.
Measured: Day1, Day29, Day57 and Day85
Change on instrumental measurement by subject
hydration index : mean value measured by a measuring pen on the skin
Measured: each day, during 3 months
Change on Subject's evaluations : subject evaluation
PO-SCORAD : a fully validated self-assessment of the AD severity adapted from the SCORAD index; it is available on mobile's phone application.
Measured: each day during 3 months
Change on Subject's evaluation : subject evaluation
target PO-SCORAD : The target PO-SCORAD is the sum of all PO-SCORAD objective signs scores: dryness of the skin without eczema, redness of the skin affected by eczema, swelling, oozing/ crust, scratching and thickening evaluated on the target area
Measured: on Day1, Day29, Day57 and Day85
Change on Subject's evaluation : subject evaluation
Subject's questionnaire on lifestyle modifications, as potential flare triggers.
Measured: once a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start12 Nov 2019
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Didier COUSTOU, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553224
- Sponsor's protocol ID
- POSCORADCOLLECT
- Status last verified
- May 2020
- First submitted
- 14 May 2020
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Clinical and Biometrological Data in Adult Subjects Suffering From Atopic Dermatitis (AD) During a Three-month Period
- ClinicalTrials.gov ID
- NCT04553224
- Acronym / sponsor ID
- POSCORADCOLLECT
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 17 Sep 2020 (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 represents a real challenge in public health as it affects a large percentage of children and adults. Affected individuals must cope with a significant psychosocial burden, in addition to dealing with the medical aspects of the disease.
The purpose of this exploratory study is to collect clinical severity AD data, using PO-SCORAD (self-assessment by the subjects), SCORAD evolution, instrumental measurements and treatment follow up of subjects.
The future objective is to develop a personalised prediction model of AD flares in order to improve management of AD by more accurate severity evaluations by the subject and the physician. Development of a method of early detection of flares will open new treatment pathways for AD management.
Detailed description
This study will be conducted as a French monocentric exploratory study in adults with mild to moderate Atopic Dermatitis, and will be conducted on a maximum 25 included subjects.
The clinical study will include 4 study visits, after inclusion visit, and the maximum duration of the study for each subject will be 3 months : Day 1, Day 29, Day 57, Day 85.
In case of AD flare suspicion, the investigator may recommend a complementary visit. Any complementary visit will be confirmed by investigator according to the subject's information: photographs and PO-SCORAD sent by the subject. If visit is confirmed, it will be scheduled as soon as possible.
The objectives are:
- to collect clinical AD severity data in order to evaluate natural AD evolution with clinical and subject's scales, during a three-month period.
- to collect non-invasive instrumental AD data on a target area and on adjacent area: cutaneous hydration, epidermal barrier conditions and colorimetric parameters on cutaneous erythema
- to examine clinical and instrumental AD data
- to collect illustrative photographs of AD lesions
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Subjects | Other | Other: Clinical evaluations, Other: Non-invasive instrumental measurements, Other: Subject's evaluationsClinical and instrumental measurements |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject suffering from Atopic Dermatitis according to the U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis (3).
- Subject with mild to moderate Atopic Dermatitis with 20 <= SCORAD <= 40 at inclusion
- Subject with flare frequency ≥ 4 over the last year
- Subject with a cutaneous target area, allowing the measurements, located on upper or lower limbs and defined as a usual AD flare area according to the subject
- Subject owning a smartphone suitable with the 5.0 downloaded version of PO-Scorad® app
Key exclusion criteria (10 listed)
- Subject having received artificial UV exposure or excessive exposure to natural sunlight within the 2 weeks before the inclusion visit or planning to be exposed to excessive or prolonged natural sunlight or UV exposures for the duration of the study
- Subject with a hirsute target area
- Systemic immunosuppressive therapy (excepted systemic corticoids) within 3 months before the inclusion visit or ongoing at inclusion visit.
- Systemic corticoids taken (whatever the number of intake) within 4 weeks before the inclusion visit or ongoing at inclusion visit.
- Phototherapy performed within 4 weeks before the inclusion visit or ongoing at inclusion visit
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 |
|---|---|---|
| Clinical evaluationsSCORAD and target SCORAD | Other | All Subjects |
| Non-invasive instrumental measurementsTEWL, cutaneous hydration, skin lipidic analysis, colorimetry, hydration index | Other | All Subjects |
| Subject's evaluationsPO-SCORAD, target PO-SCORAD and subject's questionnaire | Other | All Subjects |
Primary outcome
Change on clinical evaluation (investigator evaluation) : SCORAD
Time frame: Day1, Day29, Day57 and Day85
The SCORAD is a scoring system based on the assessment of extent and intensity in a standardized manner
Change on clinical evaluation (investigator evaluation) : Target SCORAD
Time frame: Day1, Day29, Day57 and Day85
Target SCORAD is the sum of all SCORAD objective signs scores: erythema, oedema/papulation, oozing/crusts, excoriation, lichenification and dryness evaluated on a target area
Change on instrumental measurement performed by investigational team : TEWL
Time frame: Day1, Day29, Day57 and Day85
TEWL: Transepidermal water loss. TEWL tracks the passage of water through the skin
Change on instrumental measurement performed by investigational team : Lipidic analysis
Time frame: Day1, Day29, Day57 and Day85
The proportion of lipids will be analysed on specific bands of infrared spectra by calculation of area under curve of the peaks
Change on instrumental measurement performed by investigational team : cutaneous hydration
Time frame: Day1, Day29, Day57 and Day85
Cutaneous hydration evaluated by humidity of the stratum corneum. The measurement is based on capacitance measurement of the stratum corneum.
Change on instrumental measurement performed by investigational team : colorimetric parameter of cutaneous erythema
Time frame: Day1, Day29, Day57 and Day85
Evaluation with objective assessment the color of the surface of the skin. Data output will be in the form of the L* a* b* color coordinate system. The a* values (red/ green) will be assessed for quantifying the degree of erythema.
Change on instrumental measurement by subject
Time frame: each day, during 3 months
hydration index : mean value measured by a measuring pen on the skin
Change on Subject's evaluations : subject evaluation
Time frame: each day during 3 months
PO-SCORAD : a fully validated self-assessment of the AD severity adapted from the SCORAD index; it is available on mobile's phone application.
Change on Subject's evaluation : subject evaluation
Time frame: on Day1, Day29, Day57 and Day85
target PO-SCORAD : The target PO-SCORAD is the sum of all PO-SCORAD objective signs scores: dryness of the skin without eczema, redness of the skin affected by eczema, swelling, oozing/ crust, scratching and thickening evaluated on the target area
Change on Subject's evaluation : subject evaluation
Time frame: once a month
Subject's questionnaire on lifestyle modifications, as potential flare triggers.
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 17 Sep 2020.
- free mobile app: PO-Scorad®Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Didier COUSTOU, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical evaluations, Non-invasive instrumental measurements and Subject's evaluations in people with Atopic Dermatitis, run by Pierre Fabre Dermo Cosmetique 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 6 inclusion and 10 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 17 Sep 2020. 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 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?
Change on clinical evaluation (investigator evaluation) : SCORAD (time frame: Day1, Day29, Day57 and Day85). The study lists 10 primary outcomes in all. 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 17 Sep 2020.