IchthyosisNCT07783165
Patient Study to Evaluate the Safety and Emollient Performance of Doublebase Once in the Treatment of Ichthyosis
A study testing Doublebase Once in people with Ichthyosis, run by Dermal Laboratories Ltd.
Trial summary
28 Day Survey study in patients with Ichthyosis Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ichthyosis
- 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
- 7 Sep 2026to 15 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 ichthyosis 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 use Doublebase Once for one month, instead of the patients usual emollient, as part of their normal ichthyosis management for the area(s) they have selected to treat for the study? This would also involve trying to use it once daily only
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 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
28 Day Survey study in patients with Ichthyosis
Read the detailed description
Ichthyosis patients registered on the ISG/MHF database or patients responding to information on the websites will be advised about the study and asked if they maybe interested in trying Doublebase Once. Any patients interested in taking part will then be asked to register, 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 has been obtained, patients will then complete a screening questionnaire. ISG/MHF 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 packs 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 ichthyosis 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 one area affected by ichthyosis, instead of their usual leave-on emollient. If, during the study patients find that they like using Doublebase Once, they can use the product on all affected areas. 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
- Ichthyosis
- Being tested
- Doublebase Once
- Keywords
- Doublebase Once, Treatment, Ichthyosis
- Medical subject headings
- Ichthyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doublebase OnceDevice
Single daily use Emollient
| Study group | Role | What they receive |
|---|---|---|
| single arm study in approximately 100 Ichthyosis patients of any age. | Experimental | Open label Receives: Device: Doublebase Once |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire responses
Skin condition changes from baseline parameters scores 0-10 (0 = strongly agree, 10 = Strongly disagree) and product use questionnaires
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start7 Sep 2026 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IchthyosisStudies 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
- 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
- NCT07783165
- Sponsor's protocol ID
- DLPF-03
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Questionnaire responses
Study at a glance
From the registry record, last updated by the sponsor on 8 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 Ichthyosis
- ClinicalTrials.gov ID
- NCT07783165
- Acronym / sponsor ID
- DLPF-03
- Conditions
- Ichthyosis
- Keywords
- Doublebase Once, Treatment, Ichthyosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dermal Laboratories LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2026 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 24 Aug 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.
28 Day Survey study in patients with Ichthyosis
Detailed description
Ichthyosis patients registered on the ISG/MHF database or patients responding to information on the websites will be advised about the study and asked if they maybe interested in trying Doublebase Once. Any patients interested in taking part will then be asked to register, 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 has been obtained, patients will then complete a screening questionnaire. ISG/MHF 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 packs 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 ichthyosis 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 one area affected by ichthyosis, instead of their usual leave-on emollient. If, during the study patients find that they like using Doublebase Once, they can use the product on all affected areas. 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
| Arm | Type | Receives |
|---|---|---|
| single arm study in approximately 100 Ichthyosis patients of any age. | Experimental | Device: Doublebase OnceOpen label |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with ichthyosis 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 use Doublebase Once for one month, instead of the patients usual emollient, as part of their normal ichthyosis management for the area(s) they have selected to treat for the study? This would also involve trying to use it once daily only
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 OnceSingle daily use Emollient | Device | single arm study in approximately 100 Ichthyosis patients of any age. |
Primary outcome
Questionnaire responses
Time frame: 4 weeks
Skin condition changes from baseline parameters scores 0-10 (0 = strongly agree, 10 = Strongly disagree) and product use questionnaires
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 8 Sep 2026.
- Individual participant dataSharing planned: Yes. Questionnaire responses
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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 Ichthyosis, 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 8 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?
Questionnaire responses (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 8 Sep 2026.