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New treatment option for Atopic Eczema
Official title A Study to Evaluate the Emollient Performance of Doublebase Once in the Treatment of Atopic Eczema
ClinicalTrials.gov ID: NCT06453512
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- ii) Patients with atopic eczema (personal history or combined personal and familial atopy), of any severity in accordance with the NICE...
- 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...
- 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.
You likely can't join if
- 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...
- 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...
- vi) Patients with any medical condition which, in the opinion of the Investigator, may adversely influence their ability to participate in the study.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Nottingham, Nottinghamshire, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nottingham, Nottinghamshire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.