Evaluating Doublebase Once for treating atopic eczema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study is a 4-week, open-label, multi-centre clinical follow-up evaluating the emollient performance of Doublebase Once in patients with atopic eczema. Participants of all ages and severity levels will switch from their usual emollients to Doublebase Once, applying it once daily. The study will assess the effectiveness through SCORAD assessments and patient questionnaires, with a subgroup of adults undergoing additional skin hydration measurements. The aim is to gather real-world data on the product's performance in managing atopic eczema.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cripps Medical Centre
  Nottingham, Nottinghamshire, United Kingdom Recruiting

Study contacts

• Principal investigator: Simon T Royal, BMedSci BM BS — Dermal Laboratories Ltd
• Study coordinator: Valerie A Hart
• Email: valerie.hart@dermal.co.uk
• Phone: 01462 458866

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.