Condition category
Skin and Connective Tissue Diseases
Date applied
07/02/2017
Date assigned
08/02/2017
Last edited
19/05/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Skin conditions are the most common reason that people go to their General Practitioner (GP) with a new problem, with around 24% of the population a year consulting their GP with a skin problem. Atopic dermatitis (atopic eczema) is a condition that causes the skin to become itchy, red, dry and cracked. It is one of the most common skin conditions, affecting up to 20% of children and 3% of adults worldwide. Despite currently available effective treatments, there is a need for new treatments which could be safely used as frequent and/or long-term treatments. Intestinal (gut) bacteria may play a role in the development of atopic skin conditions, so treatments targeting the gut could provide a new approach for the prevention and management of these conditions. Intestinal adsorbents, medications which can help normalise the gut bacteria and remove toxins from the gut, are used to treat skin conditions in some countries including Russia and Ukraine. However, more research is needed to demonstrate that intestinal adsorbents can be beneficial in the treatment of skin conditions, at least in certain types of patients. The aim of this study is to assess the effectiveness of an over-the-counter intestinal adsorbent, Enterosgel®, in adult patients with acute dermatitis. The levels of selected substances in the blood (biomarkers) are also measured to investigate their role in dermatitis and to test whether they could be used to predict how patients respond to treatment.

Who can participate?
Patients aged 18 to 60 with acute dermatitis

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in one group receive Enterosgel® in addition to standard-of-care treatment. Participants in the other group receive only standard-of-care treatment. Each patient remains in the study for 28 days and attends two study visits at the medical practice (Days 0 and 14). In addition, a research nurse phones the patients on Days 3, 7, 21 and 28 to ask about symptoms, any adverse events (side effects) and treatment use. The first visit involves a thorough assessment of symptoms by a GP who does not know which group the patient is allocated to at the end of the visit. Patients are also asked to provide a blood sample to measures the levels of biomarkers, and to keep a daily diary about their symptoms and use of treatments until Day 28.

What are the possible benefits and risks of participating?
The researchers cannot promise participants any direct benefit, but participation in the study may provide important information to improve treatments for atopic skin conditions. The procedures performed in this study are used in routine care and do not pose any significant risks. Taking a blood sample can cause some minor discomfort. All medications are standard treatments for atopic dermatitis. Enterosgel® is not currently used for treating dermatitis in the UK, but is available to treat diarrhoea and food poisoning. No adverse reactions to this treatment have been reported. However, research suggests that nausea, vomiting or constipation can occur in very rare instances.

Where is the study run from?
1. The Village Practice (UK)
2. Pickering Medical Practice (UK)
3. Rame Group Practice (UK)
4. Rowen Surgery (UK)
5. Bradford Road Medical Centre (UK)
6. White Horse Health Centre, Westbury Group Practice (UK)

When is the study starting and how long is it expected to run for?
September 2016 to April 2018

Who is funding the study?
Bioline Products s.r.o

Who is the main contact?
1. Mrs Elena Markaryan
2. Dr Preeti Pandya

Trial website

Contact information

Type

Public

Primary contact

Mrs Elena Markaryan

ORCID ID

Contact details

Enteromed Ltd
10 John Street
London
WC1N 4EB
United Kingdom

Type

Scientific

Additional contact

Dr Preeti Pandya

ORCID ID

Contact details

The Village Practice
Thornton Medical Centre
Church Road
Thornton-Cleveleys
FY5 2TZ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ENT03UK

Study information

Scientific title

Randomised, multi-centre study to assess efficacy, tolerability and safety of Enterosgel® in the treatment of acute atopic dermatitis in adults

Acronym

Study hypothesis

The hypothesis is that the over-the-counter intestinal adsorbent, Enterosgel®, used in combination with standard-of-care treatment results in better clinical outcomes in the treatment of acute atopic dermatitis than standard-of-care treatment alone.

Ethics approval

North West - Preston Research Ethics Committee, 03/04/2017, ref: 17/NW/0131

Study design

4-week randomised controlled assessor-blinded multi-centre post-marketing efficacy and safety study of a medical device

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Atopic dermatitis

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.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Dermatitis severity and symptoms, assessed by a blinded GP using the SCORing Atopic Dermatitis (SCORAD) Score on Day 14 (+/- 2 days)

Secondary outcome measures

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-α) and dermatitis severity (SCORAD, POEM) on Day 0 and on Day 14
2. Change in IgE, LPS and TNF-α from Day 0 to Day 14

A +/- 2 day window is allowed for all phone calls/visits

Overall trial start date

01/09/2016

Overall trial end date

15/04/2018

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

44

Participant 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

Recruitment start date

01/09/2017

Recruitment end date

01/03/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Village Practice
FY5 2TZ
United Kingdom

Trial participating centre

Pickering Medical Practice
YO18 8BL
United Kingdom

Trial participating centre

Rame Group Practice
PL11 2PD
United Kingdom

Trial participating centre

Rowen Surgery
SN15 2SB
United Kingdom

Trial participating centre

Bradford Road Medical Centre
BA14 9AR
United Kingdom

Trial participating centre

White Horse Health Centre, Westbury Group Practice
BA13 3FQ
United Kingdom

Sponsor information

Organisation

Enteromed Ltd

Sponsor details

10 John Street
London
WC1N 4EB
United Kingdom

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Bioline Products s.r.o.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Study results will be submitted for presentation(s) at dermatology conference(s) and for publication in international peer-reviewed scientific journal(s). Submissions are expected by end of June 2018 for publication by end of 2018.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Mrs Elena Markaryan

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

19/05/2017: The following changes were made to the trial record: 1. The recruitment start date was changed from 01/04/2017 to 01/09/2017. 2. The recruitment end date was changed from 30/09/2017 to 01/03/2018. 3. The overall trial end date was changed from 31/10/2017 to 15/04/2018.