The role of Staphylococcus Aureus and the bacterial skin flora during flare-up and resolution of atopic eczema

Phase 1

• Conditions: Atopic dermatitis; MedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; MedDRA version: 23.0Level: LLTClassification code 10084010Term: Atopic dermatitis flareSystem Organ Class: 100000004858; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2021-006883-25-DK
• Lead Sponsor: Bispebjerg hospital, Dermato-Venerologisk afdeling, Jacob Pontoppidan Thyssen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-21
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

INCLUSION CRITERIA:
-Age 18 years or above
-European ancestry
-AD diagnosis according to Hanifin & Rajka criteria
-AD for at least 3 years
-AD that is moderate-to-severe defined as an EASI score of = 7
-AD in the sampled location that has an TLSS score of = 5

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

EXCLUSION CRITERIA:
-Current or present systemic immunosuppressant and/or biological treatment for the past 4 weeks
-Evidence of other concomitant inflammatory skin conditions (e.g., psoriasis or contact dermatitis)
-Evidence of active skin infection that warrants treatment at screening or baseline visit
-Systemic or topical antibiotics in the preceding past 4 weeks
-Use of disinfectants, bleach and potassium permanganate baths at least 2 weeks before sampling
-UV therapy within the last 3 weeks, or pronounced exposure to sunlight in the preceding 2 weeks
-History of any condition (e.g. bleeding diathesis) that may predispose the patient to complications associated with the planned skin biopsy procedures
-Other clinically significant medical disease that is uncontrolled despite treatment that is likely, in the opinion of the investigator, to impact the patient’s ability to participate in the study or to impact the study pharmacodynamic, or safety assessments
-Decreased kidney function (GFR under 60 ml/min)
-Tendency to formation of keloid scars
-Penicillin or mometasone futurate allergy or intolerance
-Pregnancy
-Breast feeding
-Body weight = 40 kg
-AD only located in the face or intimate regions

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified