Patient Study to Evaluate the Safety and Emollient Performance of Doublebase Once in the Treatment of Psoriasis
Study Overview
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Main Group
Doublebase Once
|
Once Daily Emollient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
4 weeks use
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse Device effects and Device deficiencies
Time Frame: weeks 1 - 4
|
Reported related adverse device effects and Device deficiencies
|
weeks 1 - 4
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DLPF-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.