Atopic DermatitisNCT05502185
Targeting Staphylococci in Atopic Dermatitis
An observational study of Atopic Dermatitis, run by L'Oreal.
Trial summary
The aim of the study is to deliver a better understanding of the molecular mechanisms used by S. epidermidis strains in their adhesion and colonization on the stratum corneum across a broad spectrum of atopic dermatitis in mild to moderate conditions in adult patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Sep 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 60 participants (30 healthy volunteers and 30 AD patients)
Who may be able to join
- • Male/Female subject from 18 years old or above.
- Subject willing and able to fulfil the study requirements and schedule
- Subject informed about the study objectives and procedures, and able to understand them
- Subject who has given written informed consent
- Subject with I, II, III or IV skin phototype
- Specific criteria:
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- For AD patients:
- Subject diagnosed with AD (via UK working party criteria) with a mild-to-moderate severity defined as EASI<32 and vIGA between 2 and 3
- Subject with at least one AD lesion covering at least 4 cm²
- For healthy volunteers:
- Subject matching the demographic characteristics of a patient included in the AD group: same sex, same phototype, same age (± 5 years)
Who cannot join
- Subject with a body mass index (BMI) higher than 40
- Presenting another dermatological condition that could interfere with the clinical evaluation
- Presenting any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator
- Topical or systemic treatment that could interfere with the study treatment/assessments (topical benzoyl peroxide, salicylic acid and other anti-acne or antiseborrheic products, antibiotics, corticosteroids, retinoids, differin gel, retin-A, anti-inflammatory drugs, within the 4 weeks prior to the participation in the study.
- Any physical treatment including laser or phototherapy (PUVA, IPL, PDT), topical fillers such as Botox on the investigational sites in the last 6 months and during the study
- Subject treated with systemic non-steroidal anti-inflammatory drugs (≥3 days) within 1 week before the inclusion visit or intending to be treated with it during the study.
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- Subject treated with biological immunosuppressive drugs within 12 weeks prior to the inclusion visit or intending to be treated with it during the study.
- Subject treated with non-biological immunosuppressive drugs within 4 weeks prior to the inclusion visit or intending to be treated with it during the study.
- Subject treated with systemic corticoids within 1 week prior to the inclusion visit or planed during the study.
- Subject treated with systemic antibiotics within 2 weeks prior to the inclusion visit or planned during the study.
- Subject having applied topical corticosteroids and topical calcineurin inhibitors on the investigational areas within 1 week prior to the inclusion visit.
- Subject having applied topical immunomodulators, non-steroidal anti-inflammatory, antihistamines on investigational area within 1 week prior to the inclusion visit.
- Subject having applied topical antibiotics or disinfectants on investigational area within 2 weeks prior to the inclusion visit.
- Subject having applied any other topical and/or care product within 12 hours of the visit.
- Subject having applied water or care product (except hands cleaning) within 12 hours prior to the inclusion visit.
- Subject having significant dermatological condition or sign (e.g disease, scare, abundant hairiness, tanning mark…) that according to the investigator's judgment, could limit the observations or/and interfere with the interpretations.
- Subject having performed phototherapy within 8 weeks prior to the inclusion visit or intending to perform phototherapy during the study.
- Subject having performed another physical treatment (e.g radiotherapy…) on the investigational areas within 6 months prior to the inclusion visit or intending to perform it during the study.
- Subject having exposed their skin to natural or artificial UV within 2 weeks prior to the inclusion visit
- Subject under legal guardianship or incapacitation.
- Subject who declares to be deprived of freedom by administrative or legal decision
- Subject linguistically or psychologically unable of signing informed consent form and unable to comply with the protocol requirements according to the investigator's judgment.
- Subject who cannot be contacted by telephone in case of emergency.
- Subject having participated within the 30 days before inclusion or currently participating in another clinical study.
Trial locations and contacts
No sites are listed yet.
Magali MOREAU, pHD contact
About this study
Official title: Targeting Staphylococci Adhesion and Colonization on the Surface of Corneocytes in Atopic Dermatitis
The aim of the study is to deliver a better understanding of the molecular mechanisms used by S. epidermidis strains in their adhesion and colonization on the stratum corneum across a broad spectrum of atopic dermatitis in mild to moderate conditions in adult patients.
Read the detailed description
Recent studies have shown that while in severe cases of AD the density of S. aureus is increased in lesions, the skin of adult patients with low to mild AD were overpopulated with S. epidermidis and not S. aureus.
the aim is to characterize the S. epidermidis colonization and adhesion, with the Analyzis of skin and microbiota samples to identify and characterize S. epidermidis strains involved in corneocytes adhesion.
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Bacterial adhesion
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | no intervention | |
| Atopic Dermatitis patients | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of S. epidermidis adhesins
Identification of S. epidermidis adhesins involved in corneocytes adhesion, in mild-to moderate AD conditions
Measured: 1 week
Secondary outcomes (1)
characterization of corneocytes
characterization of corneocytes morphology from clinical sourcing of lesional and non lesional zones of AD subjects, mild-to-moderate and healthy volunteers, and characterization of the interaction between S. epidermidis adhesins and AD corneocytes
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- L'Oreal
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan IRVINE, MD, Principal investigator, Clinical Research Facility in Trinity College of Dublin/St. James Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502185
- Sponsor's protocol ID
- ACR_TCDUB_22-11995
- Status last verified
- Aug 2022
- First submitted
- 12 Jul 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Staphylococci Adhesion and Colonization on the Surface of Corneocytes in Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05502185
- Acronym / sponsor ID
- ACR_TCDUB_22-11995
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Bacterial adhesion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- L'OrealIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 16 Aug 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 deliver a better understanding of the molecular mechanisms used by S. epidermidis strains in their adhesion and colonization on the stratum corneum across a broad spectrum of atopic dermatitis in mild to moderate conditions in adult patients.
Detailed description
Recent studies have shown that while in severe cases of AD the density of S. aureus is increased in lesions, the skin of adult patients with low to mild AD were overpopulated with S. epidermidis and not S. aureus.
the aim is to characterize the S. epidermidis colonization and adhesion, with the Analyzis of skin and microbiota samples to identify and characterize S. epidermidis strains involved in corneocytes adhesion.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | –no intervention |
| Atopic Dermatitis patients | – | –no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 60 participants (30 healthy volunteers and 30 AD patients)
Key inclusion criteria (11 listed)
- • Male/Female subject from 18 years old or above.
- Subject diagnosed with AD (via UK working party criteria) with a mild-to-moderate severity defined as EASI<32 and vIGA between 2 and 3
- Subject with at least one AD lesion covering at least 4 cm²
- Subject matching the demographic characteristics of a patient included in the AD group: same sex, same phototype, same age (± 5 years)
Key exclusion criteria (24 listed)
- Subject with a body mass index (BMI) higher than 40
- Presenting another dermatological condition that could interfere with the clinical evaluation
- Presenting any concomitant medical condition that may interfere with the study conduct in the opinion of the investigator
- Topical or systemic treatment that could interfere with the study treatment/assessments (topical benzoyl peroxide, salicylic acid and other anti-acne or antiseborrheic products, antibiotics, corticosteroids, retinoids, differin gel, retin-A, anti-inflammatory drugs, within the 4 weeks prior to the participation in the study.
- Any physical treatment including laser or phototherapy (PUVA, IPL, PDT), topical fillers such as Botox on the investigational sites in the last 6 months and during the study
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
Identification of S. epidermidis adhesins
Time frame: 1 week
Identification of S. epidermidis adhesins involved in corneocytes adhesion, in mild-to moderate AD conditions
1 secondary outcome
characterization of corneocytes
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- 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.
Magali MOREAU, pHD contact
Alan IRVINE, MD principal investigator
Clinical Research Facility in Trinity College of Dublin/St. James Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by L'Oreal.
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 24 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 16 Aug 2022. 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 AUDREY GUENICHE, pHD (0660992467, audrey.gueniche@rd.loreal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of S. epidermidis adhesins (time frame: 1 week). 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 16 Aug 2022.