Actively Recruiting
A Study to Evaluate the Emollient Performance of Doublebase Once in the Treatment of Atopic Eczema
Led by Dermal Laboratories Ltd · Updated on 2025-03-18
65
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
Sponsors
D
Dermal Laboratories Ltd
Lead Sponsor
N
Nottingham University Hospitals NHS Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Emollient Performance of Doublebase Once in the Treatment of Atopic Eczema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with atopic eczema of any severity according to NICE categorisation
- Baseline SCORAD score of at least 15
- Able to read and understand the patient information sheet and sign Consent/Assent Form
- Currently managing eczema with regular leave-on emollients
- Not currently using systemic or topical antibiotics or Doublebase Once
- Willing to use Doublebase Once once daily as their only leave-on emollient for 4 weeks
- Willing to continue their usual cleansing routine or use Doublebase Once as a soap substitute
- For skin hydration subgroup: baseline corneometry measurement of 40 arbitrary units or less
You will not qualify if you...
- Currently using or used systemic or topical antibiotics or Doublebase Once in the past month
- Known intolerance or skin sensitivity to ingredients in Doublebase Once or similar products
- Participating in another study or participated in one within the past 30 days
- Difficulty completing the questionnaire written in English
- Employees of the sponsor or investigators, or immediate family members of such employees
- Medical conditions that may affect ability to participate, as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cripps Medical Centre
Nottingham, Nottinghamshire, United Kingdom
Actively Recruiting
Research Team
V
Valerie A Hart
CONTACT
J
Jennine L Walker
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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