PsoriasisNCT07817394
Patient Study to Evaluate the Safety and Emollient Performance of Doublebase Once in the Treatment of Psoriasis
A study testing Doublebase Once in people with Psoriasis, run by Dermal Laboratories Ltd.
Trial summary
This PMCF study is to obtain patient feedback using online questionnaires. There will be no involvement from healthcare professionals (HCPs) or investigator sites. Up to 100 Patients are being recruited by My Health Focus through their website. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psoriasis
- 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
- 100 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2026to 31 Oct 2026
- 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
- Patients with psoriasis of any severity previously diagnosed by a Healthcare Professional (HCP).
- Patients normally managing their skin condition by regular and ongoing use of leave-on emollient(s).
- Patients willing to incorporate Doublebase Once into their normal skin condition management routine for approximately 1 month as their only emollient and instead of their usual emollient
Who cannot join
- Does not regularly use an emollient
- 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 used.
- Currently participating in a study involving an investigational medicinal product/medical device or having participated in the previous 30 days.
- Patients currently residing in Northern Ireland (this is due to the different approval process)
- Patients (or their parents/legal guardians, in the case of infants, very young children or adolescent adults) who may have difficulties completing the feedback questionnaires, which will be written in English only.
- Employees of My Health Focus or the Sponsor (Dermal or the Diomed group companies), or any immediate family member (partner, offspring, parents, siblings or sibling's offspring) of such employees
About this study
This PMCF study is to obtain patient feedback using online questionnaires. There will be no involvement from healthcare professionals (HCPs) or investigator sites. Up to 100 Patients are being recruited by My Health Focus through their website. The study is performed throughout the UK except Northern Ireland with no sites involved in this study. Patients apply directly to participate in the study and the testing and questionnaire responses are completed at home.
Read the detailed description
The study is to be performed in liaison with My Health Focus who have been set up to help support, educate and promote research for psoriasis patients. The intention is to utilise their website and patient database to recruit to this study under the management of My Health Focus. This will allow psoriasis patients to access this treatment free of charge and for the Sponsor to obtain key information about how psoriasis patients use Doublebase Once.
Psoriasis patients registered on the My Health Focus database will be advised about the study by adverts on the My Health Focus website or social medial posts and direct email via My Health Focus mailing list. This will briefly summarise the study, the rationale for performing it, and a description of what participation will involve. Any patients interested in taking part will then be asked to register interest by completing a short questionnaire that will be used as a pre-screen tool to exclude any patients who are ineligible for the study.
Patients will then be provided with the Patient Information Sheet (PIS) to read and then complete a consent questionnaire, confirming their agreement to participate in the study. Once consent and assent (where applicable) have been obtained, patients will then complete a screening questionnaire and provide details to fulfil their supplies. My Health Focus and the Sponsor will require access to personal information such as email addresses (for sending the questionnaires and safety monitoring) and home addresses (for sending the packs of Doublebase Once), but these details will be used solely for the purpose of the study.
If all screening questions are completed and the patient is eligible in accordance with the inclusion and exclusion criteria, the patient will then be sent two pump pack of Doublebase Once 500g.
On receipt of their pack(s) of Doublebase Once (Day 0), the patients will be asked to read through all the information provided and to complete an online questionnaire and, if they agreed at consent, they will be asked to photograph one area of their psoriasis that will be treated with the product and upload to the database alongside their questionnaire. Guidance on taking the photos will be provided in the questionnaire with regards to lighting, location, distance, angle of taking photographs, and background. This questionnaire and image(s) will form the baseline 'before using Doublebase Once' and there will be some questions to be completed immediately after first use of the product.
Patients will then be asked to use Doublebase Once, as per the package leaflet for approximately 4 weeks, once daily (unless they need to use it more often) and on their affected psoriasis areas, instead of their usual leave-on emollient. Patients will also be asked to use Doublebase Once instead of their usual wash product. If patients do not want to use Doublebase Once instead of their usual wash products, they will be asked to continue to use their usual products.
While using the product, the patients will be sent further questionnaires to complete on Day 8 and 29 and if they consented to do so, to send further photographs of the same area taken at Day 0.
At the end of the study as part of the final questionnaire, patients will be asked to provide a short review about Doublebase Once and give the product a 'star rating' out of 5 (5 being excellent and 1 being poor).
- Conditions
- Psoriasis
- Being tested
- Doublebase Once
- Keywords
- PMCF Survey
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doublebase OnceDevice
Once Daily Emollient
| Study group | Role | What they receive |
|---|---|---|
| Main Group | Experimental | Doublebase Once Receives: Device: Doublebase Once |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emollient performance
Patient reported questionnaire responses on skin condition and product use. Scoring of 0 - 10 to specific skin condition and product parameters (0=Strongly agree - 10 strongly disagree)
Measured: 4 weeks use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start21 Sep 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, open label study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dermal Laboratories Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817394
- Sponsor's protocol ID
- DLPF-04
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient Reported Outcomes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Study to Evaluate the Safety and Emollient Performance of Doublebase Once in the Treatment of Psoriasis
- ClinicalTrials.gov ID
- NCT07817394
- Acronym / sponsor ID
- DLPF-04
- Conditions
- Psoriasis
- Keywords
- PMCF Survey
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dermal Laboratories LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 14 Sep 2026 (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.
This PMCF study is to obtain patient feedback using online questionnaires. There will be no involvement from healthcare professionals (HCPs) or investigator sites. Up to 100 Patients are being recruited by My Health Focus through their website. The study is performed throughout the UK except Northern Ireland with no sites involved in this study. Patients apply directly to participate in the study and the testing and questionnaire responses are completed at home.
Detailed description
The study is to be performed in liaison with My Health Focus who have been set up to help support, educate and promote research for psoriasis patients. The intention is to utilise their website and patient database to recruit to this study under the management of My Health Focus. This will allow psoriasis patients to access this treatment free of charge and for the Sponsor to obtain key information about how psoriasis patients use Doublebase Once.
Psoriasis patients registered on the My Health Focus database will be advised about the study by adverts on the My Health Focus website or social medial posts and direct email via My Health Focus mailing list. This will briefly summarise the study, the rationale for performing it, and a description of what participation will involve. Any patients interested in taking part will then be asked to register interest by completing a short questionnaire that will be used as a pre-screen tool to exclude any patients who are ineligible for the study.
Patients will then be provided with the Patient Information Sheet (PIS) to read and then complete a consent questionnaire, confirming their agreement to participate in the study. Once consent and assent (where applicable) have been obtained, patients will then complete a screening questionnaire and provide details to fulfil their supplies. My Health Focus and the Sponsor will require access to personal information such as email addresses (for sending the questionnaires and safety monitoring) and home addresses (for sending the packs of Doublebase Once), but these details will be used solely for the purpose of the study.
If all screening questions are completed and the patient is eligible in accordance with the inclusion and exclusion criteria, the patient will then be sent two pump pack of Doublebase Once 500g.
On receipt of their pack(s) of Doublebase Once (Day 0), the patients will be asked to read through all the information provided and to complete an online questionnaire and, if they agreed at consent, they will be asked to photograph one area of their psoriasis that will be treated with the product and upload to the database alongside their questionnaire. Guidance on taking the photos will be provided in the questionnaire with regards to lighting, location, distance, angle of taking photographs, and background. This questionnaire and image(s) will form the baseline 'before using Doublebase Once' and there will be some questions to be completed immediately after first use of the product.
Patients will then be asked to use Doublebase Once, as per the package leaflet for approximately 4 weeks, once daily (unless they need to use it more often) and on their affected psoriasis areas, instead of their usual leave-on emollient. Patients will also be asked to use Doublebase Once instead of their usual wash product. If patients do not want to use Doublebase Once instead of their usual wash products, they will be asked to continue to use their usual products.
While using the product, the patients will be sent further questionnaires to complete on Day 8 and 29 and if they consented to do so, to send further photographs of the same area taken at Day 0.
At the end of the study as part of the final questionnaire, patients will be asked to provide a short review about Doublebase Once and give the product a 'star rating' out of 5 (5 being excellent and 1 being poor).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, open label study
| Arm | Type | Receives |
|---|---|---|
| Main Group | Experimental | Device: Doublebase OnceDoublebase Once |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with psoriasis of any severity previously diagnosed by a Healthcare Professional (HCP).
- Patients normally managing their skin condition by regular and ongoing use of leave-on emollient(s).
- Patients willing to incorporate Doublebase Once into their normal skin condition management routine for approximately 1 month as their only emollient and instead of their usual emollient
Key exclusion criteria (6 listed)
- Does not regularly use an emollient
- 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 used.
- Currently participating in a study involving an investigational medicinal product/medical device or having participated in the previous 30 days.
- Patients currently residing in Northern Ireland (this is due to the different approval process)
- Patients (or their parents/legal guardians, in the case of infants, very young children or adolescent adults) who may have difficulties completing the feedback questionnaires, which will be written in English only.
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 OnceOnce Daily Emollient | Device | Main Group |
Primary outcome
Emollient performance
Time frame: 4 weeks use
Patient reported questionnaire responses on skin condition and product use. Scoring of 0 - 10 to specific skin condition and product parameters (0=Strongly agree - 10 strongly disagree)
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 14 Sep 2026.
- Individual participant dataSharing planned: Yes. Patient Reported Outcomes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Doublebase Once in people with Psoriasis, run by Dermal Laboratories Ltd.
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 3 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: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emollient performance (time frame: 4 weeks use). 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 14 Sep 2026.