Status:
COMPLETED
Staphylococcus Aureus in Atopic Dermatitis Immunopathology
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Atopic Dermatitis (AD) is a frequent inflammatory skin disease characterized by recurrent eczema. It associates genetic/epigenetic-induced alterations of epidermal barrier and type-2 inflammation/hype...
Eligibility Criteria
Inclusion
- Subject over 18 years of age
- Subject able to read, understand and give documented informed consent
- Subject who gave written informed consent
- Subject willing and able to comply with the protocol requirements for the duration of the study
- Subjects with health insurance coverage according to local regulations
- For woman with childbearing potential;
- Use of a highly effective method of birth control from at least 1 month prior to study enrollment until the last visit
- Negative urine pregnancy test at inclusion visit
- Subject with I, II, III or IV skin phototype (according to Fitzpatrick scale)
- Subject accepting patch-tests and skin biopsies Specific criteria for AD patients
- Subject diagnosed with moderate-to-severe AD, defined as EASI ≥7 and DLQI ≥ 6
- Subject with AD involvement of ≥ 5% of Body Surface Area (BSA)
- Subject with at least one AD lesion:
- Located either on upper extremities (except hands) or lower extremities (except feet)
- With a sufficient extent to allow all the investigations
- With a lesional area score ≥ 6
Exclusion
- Pregnancy or breast-feeding women, or planning to become pregnant or breastfeed during the study
- History of allergic reaction to local anesthetic product
- History of wound healing disorders (e.g. hypertrophic scars, keloids)
- Subject with known active infection to HBV, HCV or HIV
- Subject with known blood dyscrasia
- Subject having applied topical immunomodulators, non-steroidal anti-inflammatory, corticoids, antihistamines, antibiotics or disinfectants on investigational limbs within 1 week before the inclusion visit
- Subject treated with cyclosporine, methotrexate oral corticosteroids, azathioprine, mycophenolate-mofetil, and/or any other systemic immunosuppressor/immunomodulator within 4 weeks before the study
- Subject treated by a biologic therapy within 3 months before the study
- Subject treated with ultraviolet therapy within 4 weeks before study
- Subject presenting clinically significant medical disease that is uncontrolled despite treatment that is likely, in the opinion of the investigator, to impact patient's ability to participate in the study or to impact the study efficacy or safety assessments
- Subject treated with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
- Subject with immunocompromised people in its close circle
- Subject protect by the law (adult under guardianship, or hospitalized in a public or private institution for a reason other than study, or incarcerated)
- Subject in an exclusion period from a previous study or who is participating in another clinical trial
- Specific criteria for AD patients :
- o Subject currently experiencing or having a history of other concomitant skin conditions that would interfere with evaluation of AD
- Specific criteria for healthy control :
- Subject currently experiencing or having an history of AD or other concomitant condition that would interfere with evaluation of skin reaction induced by patch test
Key Trial Info
Start Date :
October 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04715087
Start Date
October 26 2022
End Date
January 31 2025
Last Update
September 11 2025
Active Locations (1)
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1
Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69495