💬In plain words
What the trial is, and whether it could suit you
A 4 week, open label, multi-centre (GP setting), post market clinical follow-up study with Doublebase Once in patients of any age and any severity of atopic eczema.
The study will involve patients who are already using emollients as part of their treatment regime, switching to Doublebase Once. Patients will ideally apply the product once daily for 4 weeks and SCORAD assessments will be performed, and patient questionnaires will be completed. A subgroup of adult patients (up to 15 patients) will also undergo skin hydration measurements for the first 8 days to evaluate objective measurements of skin hydration in patients with atopic eczema.
Photographs of the same, representative area of eczema will also be taken for all patients at baseline and after 4 weeks of using Doublebase Once.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* ii) Patients with atopic eczema (personal history or combined personal and familial atopy), of any severity in accordance with the NICE categorisation set out in the table below.
iii) Baseline SCORAD assessment score of at least 15. iv) Patients or their parents/ legal guardians must be able to read and understand the patient information sheet and sign the Consent Form/Assent Form.
v) Patients normally managing their eczema by regular and ongoing use of leave-on emollient(s).
vi) Patients who are not currently using systemic or topically applied antibiotics or Doublebase Once.
vii) Patients who are willing to use Doublebase Once, once daily, as their only leave-on emollient, for 4 weeks.
viii) Patients who are willing to continue to use their standard cleansing regime and/or Doublebase Once as a soap substitute for the duration of the study.
Additional inclusion criterion for subgroup for skin hydration assessments:
i) Baseline corneometry measurement of ≤40 arbitrary units.
Exclusion Criteria:
i) Are currently using or have used in the previous month, any systemic or topically applied antibiotics or Doublebase Once for their atopic eczema.
ii) Have a known history of intolerance or skin sensitivity to any of the ingredients of Doublebase Once (as identified on the patient information sheet and product labelling), or similar products.
iii) Currently participating in any other ongoing research studies or have participated in a study in the previous 30 days.
iv) Patients, or their parents/ legal guardians, who may have difficulties completing the questionnaire, which will be written in English only.
v) Employees of the Sponsor or Investigators, or any immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of such employees.
vi) Patients with any medical condition which, in the opinion of the Investigator, may adversely influence their ability to participate in the study.
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