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

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).

Inclusion criteria

• 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

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 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