Investigating Staphylococcus Aureus in Atopic Dermatitis
Staphylococcus Aureus in Atopic Dermatitis Immunopathology
This study is trying to see how the bacteria Staphylococcus aureus affects the skin inflammation in people with atopic dermatitis and if it relates to how severe their symptoms are.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Pierre-Bénite) |
| Trial ID | NCT04715087 on ClinicalTrials.gov |
What this trial studies
This study focuses on understanding the role of Staphylococcus aureus in the inflammation associated with atopic dermatitis (AD). It involves collecting blood samples, skin swabs, and performing patch tests and skin biopsies to analyze the immunopathology of AD patients. The research aims to explore the correlation between S. aureus colonization and the severity of AD symptoms. By examining these factors, the study seeks to provide insights into potential therapeutic targets for managing AD.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with moderate-to-severe atopic dermatitis.
Not a fit: Patients with mild atopic dermatitis or those not willing to undergo skin biopsies and patch tests may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients suffering from atopic dermatitis.
How similar studies have performed: Previous studies have indicated a significant relationship between S. aureus colonization and atopic dermatitis severity, suggesting this approach has a foundation in existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Pierre-Bénite
- Centre Hospitalier Lyon Sud — Pierre-Bénite, France (Recruiting)
Study contacts
- Principal investigator: Audrey NOSBAUM, MD, PhD — Allergy and Clinical Immunology Department - Centre Hospitalier Lyon Sud
- Study coordinator: Audrey NOSBAUM, MD, PhD
- Email: audrey.nosbaum@chu-lyon.fr
- Phone: 04 78 86 12 85
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.