Targeting Staphylococci in Atopic Dermatitis

NCT05502185 | Unknown DMC

• 1 other identifier: ACR_TCDUB_22-11995
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; Bacterial adhesion

Outcome Measures

Primary Outcomes (1)

• Identification of S. epidermidis adhesins

  Identification of S. epidermidis adhesins involved in corneocytes adhesion, in mild-to moderate AD conditions

  1 week

Secondary Outcomes (1)

• characterization of corneocytes

  1 week

Study Arms (2)

healthy volunteers

no intervention

Atopic Dermatitis patients

no intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

60 participants (30 healthy volunteers and 30 AD patients)

You may qualify if:

• 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:
• 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)

You may not qualify if:

• 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 having applied any other topical and/or care product within 12 hours of the 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 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.

Sponsors & Collaborators

• L'Oreal: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

corneocytes (stratum corneum upper layer of the dead skin part without nucleus and DNA)

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Alan IRVINE, MD

  Clinical Research Facility in Trinity College of Dublin/St. James Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AUDREY GUENICHE, pHD

CONTACT

0660992467; audrey.gueniche@rd.loreal.com

Magali MOREAU, pHD

CONTACT

magali.moreau2@rd.loreal.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: August 16, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share