Evaluating Doublebase Once for treating atopic eczema
A Study to Evaluate the Emollient Performance of Doublebase Once in the Treatment of Atopic Eczema Using SCORAD, Patient Questionnaires and Skin Hydration Measurements
This study is testing if using Doublebase Once once a day can help people of all ages with atopic eczema feel better compared to their usual creams.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Sex | All |
| Sponsor | Dermal Laboratories Ltd Industry-sponsored |
| Locations | 1 site (Nottingham, Nottinghamshire) |
| Trial ID | NCT06453512 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients of any age with atopic eczema who are currently using emollients and willing to switch to Doublebase Once.
Not a fit: Patients who are not currently using emollients or those with severe eczema requiring systemic treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective emollient option for patients suffering from atopic eczema.
How similar studies have performed: Other studies have shown positive outcomes with similar emollient treatments, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nottingham, Nottinghamshire
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.