Dermatitis, AtopicNCT05639738
Assessment of Clinical, Biological and Biometrological Paramaters in Adult Subjects Suffering From AD
A study testing Clinical and instrumental measurements in people with Dermatitis, Atopic, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
Trial summary
The aim of the study is to collect different parameters (clinical, biological and biometrological) of Atopic Dermatitis (AD) in order to identify which factors are modified during the flare-up phase. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Clinical and instrumental measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2022to 15 Jun 2022
- 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 aged between 18 to 50 years included
- Subject suffering from Atopic Dermatitis according to the "U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis" (6)
- Subject with mild to moderate Atopic Dermatitis with 20 <= SCORAD <= 40 at inclusion
- Subject with flare frequency ≥ 4 on the target areas 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 with a target area with 22 <= target SCORAD signs <= 10 following:
Show all 11Show fewer
- Erythema ≥ 1
- Dryness ≥ 1 1
- Subject with a control area, allowing the measurements, located on upper or lower limbs and defined as :
- A non- usual AD flare area according to the subject and the investigator
- A sufficient distance from the cutaneous target area according to the investigator
Who cannot join
- Subject with a surinfected AD
- Subject having any other dermatologic condition other than AD or characteristics (e.g: tatoo) on the target area liable to interfere with the study assessments
- Subject with another dermatologic condition, acute or chronic or disease or history of disease considered by the investigator, liable to interfere with the study assessments, or hazardous for the subject or incompatible with the study according to the investigator
- Any surgical intervention on upper or lower limbs during the previous weeks or months liable to interfere with the study data according to the investigator
- Systemic immunosuppressive therapy (excepted systemic corticoids) within 3 months before the inclusion visit or ongoing at inclusion visit (except during flare period)
- Systemic corticoids taken within 4 weeks before the inclusion visit or ongoing at inclusion visit (except during flare period)
Show all 11Show fewer
- Phototherapy performed within 4 weeks before the inclusion visit or ongoing at inclusion visit (except during flare period)
- Systemic antibiotics taken within 7 days before the inclusion visit or ongoing at inclusion visit (except during flare period)
- Moderate to high-potency topical corticosteroids applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit (except during flare period)
- Topical immunomodulators, applied within 7 days on upper or lower limbs before the inclusion visit or ongoing at inclusion visit (except during flare period)
- Topical or oral treatment instaurated or modified before the inclusion visit or planned to be instaurated during the study or ongoing at inclusion visit, liable to interfere with the study, according to the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory and Monocentric Study to Assess Clinical, Biological and Biometrological Paramaters in Adult Subjects With Mild to Moderate Atopic Dermatitis (AD)
The aim of the study is to collect different parameters (clinical, biological and biometrological) of Atopic Dermatitis (AD) in order to identify which factors are modified during the flare-up phase.
- Conditions
- Dermatitis, Atopic
- Being tested
- Clinical and instrumental measurements
- 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 and instrumental measurementsOther
- Clinical evaluations
- Non-invasive instrumental measurements
- Subject's evaluations
| Study group | Role | What they receive |
|---|---|---|
| All subject | Other | Clinical and instrumental measurements Receives: Other: Clinical and instrumental measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of clinical parameters in Atopic Dermatitis during and outside flares-up
- SCORAD (SCOring Atopic Dermatitis) and PO-SCORAD (Patient Oriented SCORing Atopic Dermatitis) are a scoring system based on the assessment of extent and intensity in a standardized manner
- 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: Change from baseline to 3 months
Colonization of microorganisms involved in Atopic Dermatitis flares-up from PCR analysis on a swab sample
Colonization of microorganisms will be expressed by percentage of each microorganism
Measured: Change from baseline to 3 months
Assessment of lipids profiles in Atopic Dermatitis by mass spectroscopy from swab samples
Each characteristic peak corresponding to specific lipid will be quantified by its mass intensity
Measured: Change from baseline to 3 months
Assessment of cutaneous hydratation in Atopic Dermatitis during and outside flares-up
Cutaneous hydration evaluated by humidity of the stratum corneum. The measurement is based on capacitance measurement of the stratum corneum.
Measured: Change from baseline to 3 months
Assessment of skin barrier condition in Atopic Dermatitis during and outside flares-up
The measurement is based on Trans-Epidermal Water Loss measurement
Measured: Change from baseline to 3 months
Assessment of pH in Atopic Dermatitis during and outside flares-up
pH evaluated by a pH-meters
Measured: Change from baseline to 3 months
Assessment of erythema in Atopic Dermatitis during and outside flares-up
Assessment the color of the surface of the skin
Measured: Change from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start8 Mar 2022
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639738
- Sponsor's protocol ID
- ADFLAREPREDICT
- Status last verified
- Nov 2022
- First submitted
- 16 Sep 2022
- Last updated
- 6 Dec 2022
- 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 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory and Monocentric Study to Assess Clinical, Biological and Biometrological Paramaters in Adult Subjects With Mild to Moderate Atopic Dermatitis (AD)
- ClinicalTrials.gov ID
- NCT05639738
- Acronym / sponsor ID
- ADFLAREPREDICT
- Conditions
- Dermatitis, Atopic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 6 Dec 2022 (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.
The aim of the study is to collect different parameters (clinical, biological and biometrological) of Atopic Dermatitis (AD) in order to identify which factors are modified during the flare-up phase.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subject | Other | Other: Clinical and instrumental measurementsClinical and instrumental measurements |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Subject aged between 18 to 50 years included
- Subject suffering from Atopic Dermatitis according to the "U.K. Working Party's Diagnostic Criteria for Atopic Dermatitis" (6)
- Subject with mild to moderate Atopic Dermatitis with 20 <= SCORAD <= 40 at inclusion
- Subject with flare frequency ≥ 4 on the target areas 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
Key exclusion criteria (11 listed)
- Subject with a surinfected AD
- Subject having any other dermatologic condition other than AD or characteristics (e.g: tatoo) on the target area liable to interfere with the study assessments
- Subject with another dermatologic condition, acute or chronic or disease or history of disease considered by the investigator, liable to interfere with the study assessments, or hazardous for the subject or incompatible with the study according to the investigator
- Any surgical intervention on upper or lower limbs during the previous weeks or months liable to interfere with the study data according to the investigator
- Systemic immunosuppressive therapy (excepted systemic corticoids) within 3 months before the inclusion visit or ongoing at inclusion visit (except during flare period)
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 and instrumental measurements* Clinical evaluations * Non-invasive instrumental measurements * Subject's evaluations | Other | All subject |
Primary outcome
Assessment of clinical parameters in Atopic Dermatitis during and outside flares-up
Time frame: Change from baseline to 3 months
* SCORAD (SCOring Atopic Dermatitis) and PO-SCORAD (Patient Oriented SCORing Atopic Dermatitis) are a scoring system based on the assessment of extent and intensity in a standardized manner * 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
Colonization of microorganisms involved in Atopic Dermatitis flares-up from PCR analysis on a swab sample
Time frame: Change from baseline to 3 months
Colonization of microorganisms will be expressed by percentage of each microorganism
Assessment of lipids profiles in Atopic Dermatitis by mass spectroscopy from swab samples
Time frame: Change from baseline to 3 months
Each characteristic peak corresponding to specific lipid will be quantified by its mass intensity
Assessment of cutaneous hydratation in Atopic Dermatitis during and outside flares-up
Time frame: Change from baseline to 3 months
Cutaneous hydration evaluated by humidity of the stratum corneum. The measurement is based on capacitance measurement of the stratum corneum.
Assessment of skin barrier condition in Atopic Dermatitis during and outside flares-up
Time frame: Change from baseline to 3 months
The measurement is based on Trans-Epidermal Water Loss measurement
Assessment of pH in Atopic Dermatitis during and outside flares-up
Time frame: Change from baseline to 3 months
pH evaluated by a pH-meters
Assessment of erythema in Atopic Dermatitis during and outside flares-up
Time frame: Change from baseline to 3 months
Assessment the color of the surface of the skin
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
Related trials for Dermatitis, Atopic
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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 Clinical and instrumental measurements in people with Dermatitis, Atopic, 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 11 inclusion and 11 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 6 Dec 2022. 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: recruitment 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?
Assessment of clinical parameters in Atopic Dermatitis during and outside flares-up (time frame: Change from baseline to 3 months). The study lists 7 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 6 Dec 2022.