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Not yet recruitingNCT07783165Updated Sep 8, 2026

Patient Study to Evaluate the Safety and Emollient Performance of Doublebase Once in the Treatment of Ichthyosis

An interventional study of Doublebase Once in Ichthyosis, sponsored by Dermal Laboratories Ltd. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Dermal Laboratories Ltd · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Sex
All
01

Study summary

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).

02

Conditions studied

  • Ichthyosis

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Keywords

  • Doublebase Once
  • Treatment
  • Ichthyosis
03

In context

Ichthyosis

33 studies on the registry are indexed under Ichthyosis; 11 are open to participants now.

This study's planned enrollment of 100 is above the median of 26 across 23 interventional studies indexed under Ichthyosis.

Browse Ichthyosis studies →

Lead sponsor

Dermal Laboratories Ltd is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    single arm study in approximately 100 Ichthyosis patients of any age.

    Open label

    Device: Doublebase Once

Interventions

  • DeviceDoublebase Once

    Single daily use Emollient

06

What researchers measure

Primary outcomes

  1. Questionnaire responses

    Skin condition changes from baseline parameters scores 0-10 (0 = strongly agree, 10 = Strongly disagree) and product use questionnaires

    Time frame: 4 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — Questionnaire responses

Supporting information: Study protocol, Statistical analysis plan

Time frame: Jan 2027

Access criteria: This registry and Publications

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07783165
Lead sponsor
Dermal Laboratories Ltd
Responsible party
Sponsor
First posted
Aug 24, 2026
Start date
Sep 7, 2026 (estimated)
Primary completion
Oct 15, 2026 (estimated)
Completion
Oct 15, 2026 (estimated)
Last update
Sep 8, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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