Atopic dermatitis Skin and Connective Tissue Diseases Atopic dermatitis
Conditions
Interventions
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
Sponsors
Enteromed Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. History of intestinal atony (severe constipation due to bowel obstruction) 2. Fever (> 39 degrees Celsius) 3. Any other clinically significant skin condition in GP's opinion 4. A history of clinically significant allergic reactions in GP's opinion 5. Use of any clinical trial investigational medication or medical devices within the last 30 days before screening visit 6. Patients with known cancer of any localisation 7. Any underlying condition that could affect the patient’s participation in this study or the results of this study in GP's opinion 8. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dermatitis severity and symptoms, assessed by a blinded GP using the SCORing Atopic Dermatitis (SCORAD) Score on Day 14 (+/- 2 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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/vis | — |
Countries
England, United Kingdom
Contacts
Public ContactElena Markaryan
Outcome results
None listed