Enterosgel® in the treatment of atopic dermatitis in adults

INTERVENTION: Patients will be randomised in 1:1 ratio using a computer‐based randomisation tool (Sealed Envelope Ltd, UK) to: 1. Control group, who will receive standard of care treatment 2. Intervention group, who will receive standard of care treatment together with an intestinal adsorbent, over‐the‐counter medical device, Enterosgel® (Biotin Products s.r.o, Czech Republic) according to study‐specific dosage, i.e. 2 tablespoons and 1 sachet a day for 14 days, and continuing on the same dosage on Days 14‐28 if the GP determines on Day 14 that treatment should be continued. Randomisation will be based on the minimisation method where treatment allocation will be stratified by study centre. Each patient will remain in the study for 28 days and attend two study visits at the medical practice (Days 0 and 14). In addition, a research nurse will phone the patients on Days 3, 7, 21 and 28 to ask about symptoms, any adverse events and treatment use. The first visit will involve confirmation of eligibility, taking informed consent and a thorough assessment of symptoms by a GP who will be blinded from the treatment group the patient is randomised to at the end of the visit. Patients will also be asked to provide a blood sample for analyses of biomarkers, and to keep a daily diary about their symptoms and manifestations and use of treatments until Day 28. CONDITION: Atopic dermatitis ; Skin and Connective Tissue Diseases ; Atopic dermatitis PRIMARY OUTCOME: Dermatitis severity and symptoms, assessed by a blinded GP using the SCORing Atopic Dermatitis (SCORAD) Score on Day 14 (+/‐ 2 days) SECONDARY OUTCOME: 1. Patient‐reported dermatitis symptoms, measured with the Patient Oriented Eczema Measure (POEM) on Days 3, 7, 14, 21 and 28 (+/‐ 2 days for all); 2. Percentage of patients with improvement in the SCORAD score from Day 0 to Day 14 (+/‐ 2 days); 3. Percentage of patients with improvement in the POEM score from Day 0 to Days 3, 7, 14, 21 and 28 (+/‐ 2 days); 4. Patient‐reported duration of individual dermatitis symptoms (n (%) days)*; 5. Treatment success, defined as not requiring any treatment for dermatitis on Day 14 (+/‐ 2 days); 6. Duration of other concomitant symptoms (n (%) days)**; 7. Duration of use of standard‐of care treatment(s) (n (%) days)**; 8. Tolerance and safety of Enterosgel®, assessed via adverse event (AE) reporting from first day of Enterosgel® intake until Day 28 (+/‐ 2 days); ; * Symptoms are the same as the symptoms in the POEM questionnaire and will be recorded in a patient diary every day from Day 0 to Day 28 (+/‐ 2 days). Duration is reported as number of days the symptom lasted calculated based on the last and first day when the symptom was recorded in the questionnaire. Duration will also be reported as % of diary days the symptom was present.; ; ** Other concomitant symptoms and treatment use will be recorded in a patient diary every day from Day 0 to Day 28 (+/‐ 2 days). Duration is reported as number of days the treatment was used calculated based on the last and first day when the treatment use was recorded in the questionnaire. Duration will also be reported as % of diary days the treatment was used; ; Exploratory outcomes:; 1. Correlation between biomarkers (IgE, LPS, TNF‐a) and dermatitis severity (SCORAD, POEM) on Day 0 and on Day 14; 2. Change in IgE, LPS and TNF‐a from Day 0 to Day 14; ; A +/‐ 2 day window is allowed for all phone calls/visits INCLUSION CRITERIA: 1. Has acute manifestations of dermatitis at the time of screening 2. Has a diagnosis of dermatitis evidenced by a read code (list of read codes provided in the protocol) 3. Aged 18 to 60 4. Able to give informed consent and complete the required study procedures, including providing a blood sample 5. Considered suitable to take part in the study in GP's opinion