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

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

28 Day Survey study in patients with Ichthyosis

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).

Inclusion Criteria:

i) Patients with ichthyosis of any severity previously diagnosed by a Healthcare Professional (HCP).

ii) Patients normally managing their skin condition by regular and ongoing use of leave-on emollient(s).

iii) Patients willing to use Doublebase Once for one month, instead of your usual emollient, as part of your normal ichthyosis management for the area(s) you have selected to treat for the study? This would also involve trying to use it once daily only

Exclusion Criteria:

i) Does not regularly use an emollient ii) 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.

iii) Currently participating in a study involving an investigational medicinal product/medical device or having participated in the previous 30 days.

iv) Patients currently residing in Northern Ireland (this is due to the different approval process).

v) 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.

vi) 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