Enterosgel® in the treatment of atopic dermatitis in adults
- Conditions
- Atopic dermatitisSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN12307286
- Lead Sponsor
- Enteromed Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 44
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dermatitis severity and symptoms, assessed by a blinded GP using the SCORing Atopic Dermatitis (SCORAD) Score on Day 14 (+/- 2 days)
- Secondary Outcome Measures
Name Time Method