Atopic EczemaNCT06453512
A Study to Evaluate the Emollient Performance of Doublebase Once in the Treatment of Atopic Eczema
A study testing Doublebase Once in people with Atopic Eczema, run by Dermal Laboratories Ltd at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atopic Eczema
- What is being tested?
- Doublebase Once
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Oct 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- 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.
- Patients normally managing their eczema by regular and ongoing use of leave-on emollient(s).
- Patients who are not currently using systemic or topically applied antibiotics or Doublebase Once.
- Patients who are willing to use Doublebase Once, once daily, as their only leave-on emollient, for 4 weeks.
- 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:
- Baseline corneometry measurement of ≤40 arbitrary units.
Who cannot join
- Are currently using or have used in the previous month, any systemic or topically applied antibiotics or Doublebase Once for their atopic eczema.
- 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.
- Currently participating in any other ongoing research studies or have participated in a study in the previous 30 days.
- Patients, or their parents/ legal guardians, who may have difficulties completing the questionnaire, which will be written in English only.
- Employees of the Sponsor or Investigators, or any immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of such employees.
- Patients with any medical condition which, in the opinion of the Investigator, may adversely influence their ability to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Cripps Medical Centre
Nottingham, Nottinghamshire
Simon Royal, Simon.Royal@nottingham.ac.uk
Daniel Hammersley, daniel.hammersley@nhs.net
About this study
Official title: A Study to Evaluate the Emollient Performance of Doublebase Once in the Treatment of Atopic Eczema Using SCORAD, Patient Questionnaires and Skin Hydration Measurements
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.
Read the detailed description
This is a prospective, open label, uncontrolled study which will be performed in multiple GP centres, in patients of all ages, who have any severity of atopic eczema. It is anticipated that approximately 75 patients will need to be screened to enrol 65 eligible patients and to complete the study with 50 evaluable patients. This study is being conducted as part of the manufacturer's undertaking to follow up the clinical performance of the device in the post marketing phase (Post Marketing Clinical Follow-up (PMCF)). It will provide additional quantitative information on the product in a real-world environment in various age groups and severities of atopic eczema using validated assessment methods and patient feedback.
Study patients will be asked to use Doublebase Once only once daily for 4 weeks, instead of their usual emollient. If they need to use Doublebase Once more frequently, this will be recorded in their patient diaries, as will any other topical or systemic treatments that they may need to use during the study period (e.g. corticosteroids). Patients will also be able to use Doublebase Once as a soap substitute.
A SCORAD assessment will be performed by the investigator/ research nurse at baseline and then after 1 and 4 weeks of treatment. Patients or their parents/ legal guardians will be asked to complete questionnaires at baseline and after 4 weeks of treatment.
A subgroup of adult patients (of up to 15 patients) will have additional skin hydration measurements (corneometry) taken before switching emollient to Doublebase Once and on 4 more occasions during the first 8 days to evaluate changes in skin hydration in patients with atopic eczema, this will be performed at the same, representative, predetermined selected area of eczema. Measurements will be taken in triplicate (and the mean calculated) and each reading and the mean value will be documented in the patients CRF at baseline, 24 hours after the first application and then again on days 3, 5 and 8 (prior to the application for that day). This subgroup will then continue in the study for the SCORAD and questionnaire follow-up at the same visit timings as the rest of the study population (see 7.12.1.1).
Photographs of one eczema affected area, which will not include any recognisable or identifiable features, private areas or details of the patient, will also be taken at baseline and again after 4 weeks of treatment.
- Conditions
- Atopic Eczema
- Being tested
- Doublebase Once
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doublebase OnceDevice
Emollient
| Study group | Role | What they receive |
|---|---|---|
| Main Study | Other | Main Study which also involves the subgroup Receives: Device: Doublebase Once |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in SCORAD after 4 weeks of treatment
The SCORAD scoring is described in section 7.4.1. For each patient, a score will be obtained at baseline, after 4 weeks. The minimum score is 0 (best outcome) and the maximum score is 103 (worst outcome). The change score will be calculated by subtracting the baseline score from the score after 4 weeks. The actual scores after 4 weeks and the change from baseline will be summarised using summary statistics. In addition, the change from baseline will be presented with a 95% confidence interval (CI), and the following hypotheses will be tested at the two-sided 5% significance level using a paired t-test.
The SCORAD score is from 0-103 and there is a minimum score of 15 at inclusion. A reduction in total score represents an improvement in the overall condition.
Measured: 4 weeks
Secondary outcomes (4)
Change from baseline in SCORAD after 1 week of treatment.
The change from baseline in SCORAD after 1 week of treatment will be summarised and analysed in the same way as the primary endpoint.
The SCORAD score is from 0-103 and there is a minimum score of 15 at inclusion. A reduction in total score represents an improvement in the overall condition.
Measured: 1 week
SCORAD individual items
Individual items of the SCORAD will be summarised using descriptive statistics (frequencies for categorical items and summary statistics for continuous measures). These items will be formally evaluated using inferential statistics by comparing values after weeks 1 and 4 versus baseline. The redness, dryness and swelling scores at week 4 will be compared to baseline using an ordinal logistic regression model for paired data. The odds of being in a better outcome category post-treatment compared to pre-treatment will be calculated with a 95% CI and p-value. The itch and sleeplessness scores post-treatment will be compared to the pre-treatment value using a paired t-test, or a Wilcoxon signed rank test if assumptions of Normality are violated. Change from baseline itch and sleeplessness (separately) will be presented with a 95% CI.
Measured: 4 weeks
Patient Questionnaire
For each of the five quality of life questions and for the sum score from the five questions, the score post-treatment will be compared to the pre-treatment value using a paired t-test.
The Patient Questionnaire (QoL) score is calculated at baseline and a reduction in total score overall represents a Patient perceived improvement in the overall condition.
Measured: 4 weeks
Skin Hydration
Skin hydration assessments will be performed in up to 15 adults and are a subgroup of the main study. The corneometry values at each visit and the change from baseline will be summarised using summary statistics. The area under the curve (AUC) over the assessment period up to Day 8 will be calculated using the trapezoidal rule.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start30 Oct 2024
- Primary completion30 May 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Post market Surveillance
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dermal Laboratories Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nottingham University Hospitals NHS Trust, Sherwood Forest Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Simon T Royal, BMedSci BM BS, Principal investigator, Dermal Laboratories Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453512
- Sponsor's protocol ID
- DLPF-01
- Status last verified
- Mar 2025
- First submitted
- 31 May 2024
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Emollient Performance of Doublebase Once in the Treatment of Atopic Eczema Using SCORAD, Patient Questionnaires and Skin Hydration Measurements
- ClinicalTrials.gov ID
- NCT06453512
- Acronym / sponsor ID
- DLPF-01
- Conditions
- Atopic Eczema
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Dermal Laboratories LtdIndustry (pharma, biotech, devices)
- Collaborators
- Nottingham University Hospitals NHS Trust, Sherwood Forest Hospitals NHS Foundation Trust
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, open label, uncontrolled study which will be performed in multiple GP centres, in patients of all ages, who have any severity of atopic eczema. It is anticipated that approximately 75 patients will need to be screened to enrol 65 eligible patients and to complete the study with 50 evaluable patients. This study is being conducted as part of the manufacturer's undertaking to follow up the clinical performance of the device in the post marketing phase (Post Marketing Clinical Follow-up (PMCF)). It will provide additional quantitative information on the product in a real-world environment in various age groups and severities of atopic eczema using validated assessment methods and patient feedback.
Study patients will be asked to use Doublebase Once only once daily for 4 weeks, instead of their usual emollient. If they need to use Doublebase Once more frequently, this will be recorded in their patient diaries, as will any other topical or systemic treatments that they may need to use during the study period (e.g. corticosteroids). Patients will also be able to use Doublebase Once as a soap substitute.
A SCORAD assessment will be performed by the investigator/ research nurse at baseline and then after 1 and 4 weeks of treatment. Patients or their parents/ legal guardians will be asked to complete questionnaires at baseline and after 4 weeks of treatment.
A subgroup of adult patients (of up to 15 patients) will have additional skin hydration measurements (corneometry) taken before switching emollient to Doublebase Once and on 4 more occasions during the first 8 days to evaluate changes in skin hydration in patients with atopic eczema, this will be performed at the same, representative, predetermined selected area of eczema. Measurements will be taken in triplicate (and the mean calculated) and each reading and the mean value will be documented in the patients CRF at baseline, 24 hours after the first application and then again on days 3, 5 and 8 (prior to the application for that day). This subgroup will then continue in the study for the SCORAD and questionnaire follow-up at the same visit timings as the rest of the study population (see 7.12.1.1).
Photographs of one eczema affected area, which will not include any recognisable or identifiable features, private areas or details of the patient, will also be taken at baseline and again after 4 weeks of treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Post market Surveillance
| Arm | Type | Receives |
|---|---|---|
| Main Study | Other | Device: Doublebase OnceMain Study which also involves the subgroup |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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.
- Patients normally managing their eczema by regular and ongoing use of leave-on emollient(s).
- Patients who are not currently using systemic or topically applied antibiotics or Doublebase Once.
- Patients who are willing to use Doublebase Once, once daily, as their only leave-on emollient, for 4 weeks.
Key exclusion criteria (6 listed)
- Are currently using or have used in the previous month, any systemic or topically applied antibiotics or Doublebase Once for their atopic eczema.
- 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.
- Currently participating in any other ongoing research studies or have participated in a study in the previous 30 days.
- Patients, or their parents/ legal guardians, who may have difficulties completing the questionnaire, which will be written in English only.
- Employees of the Sponsor or Investigators, or any immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of such employees.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doublebase OnceEmollient | Device | Main Study |
Primary outcome
Change from baseline in SCORAD after 4 weeks of treatment
Time frame: 4 weeks
The SCORAD scoring is described in section 7.4.1. For each patient, a score will be obtained at baseline, after 4 weeks. The minimum score is 0 (best outcome) and the maximum score is 103 (worst outcome). The change score will be calculated by subtracting the baseline score from the score after 4 weeks. The actual scores after 4 weeks and the change from baseline will be summarised using summary statistics. In addition, the change from baseline will be presented with a 95% confidence interval (CI), and the following hypotheses will be tested at the two-sided 5% significance level using a paired t-test. The SCORAD score is from 0-103 and there is a minimum score of 15 at inclusion. A reduction in total score represents an improvement in the overall condition.
4 secondary outcomes
Change from baseline in SCORAD after 1 week of treatment.
Time frame: 1 week
SCORAD individual items
Time frame: 4 weeks
Patient Questionnaire
Time frame: 4 weeks
Skin Hydration
Time frame: 8 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simon T Royal, BMedSci BM BS principal investigator
Dermal Laboratories Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doublebase Once in people with Atopic Eczema, run by Dermal Laboratories Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valerie A Hart (01462 458866, valerie.hart@dermal.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in SCORAD after 4 weeks of treatment (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.