CRC 386 Eczema (Dermatitis) Study

 

Study Aim:

The primary aim of this study is to assess safety and tolerability of the investigational product EDP1066 in healthy participants and patients with either mild-moderate psoriasis or mild-moderate atopic dermatitis (eczema).

EDP1066 is a strain of the bacteria species Lactococcus lactis subsp. Cremoris.  It is a naturally occurring organism commonly used in the production of a variety of food products for human consumption (including probiotic formulations, food processing and dairy manufacturing).

 

If you are interested in taking part you will be in the atopic dermatitis cohort (cohort 6).

Participant Requirements 

 

To be eligible to take part you must be:

  1. You must be aged between 18 and 60
  2. You must have mild to moderate atopic dermatitis affecting a minimum of 3% to a maximum of 15% of body surface area.
  3. You must have a confirmed diagnosis of mild to moderate dermatitis by a doctor, and have received this diagnosis more than 6 months ago. 
  4. You must be willing to have skin biopsies taken
  5. You must be willing to have photographs taken of affected areas
  6. You must not have participated in another clinical trial using investigational drug(s) within 3 months of the first treatment period.
  7. You must have an appropriate work permit (if you are not from the EU)
  8. You must have a Body Mass Index of  ≥ 18 kg/m2 to ≤ 35 kg/m2
  9. If you are female you must not be pregnant, be trying to get pregnant or breastfeeding during the study. If you are male, you must not be trying to conceive with a partner.
  10. You must be willing to provide faecal samples.
  11. You must not have received systemic non-biologic atopic dermatitis therapy (MTX, steroids, cyclophosphamide) within 4 weeks prior to Screening
  12. You has a minimum of 2 atopic dermatitis lesions with at least 1 in a site suitable for biopsy.
Information 

Please note:  This study will be running March - May 2019.

Study Visits (All timings are approximate)

Cohort 6 and 7

Visit 1 - Screening – approx. 6 hours

Visits 2-10 - outpatient visits - most visits will take approximately 2 hours with some visits taking up to 6 hours.

Visit 3 will take approximately 6 hours.

Visit 11 – Follow Up visit – approx. 3 hours

The clinical team may also phone you in between visits.

Travel Expenses – Maximum £40 per visit, determined on a zone-by-zone basis

Visit 

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