Evaluation of the Efficacy and Tolerance of the Medical Device RL3020-DP0364 in Adult Population … (NCT06800755) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Efficacy and Tolerance of the Medical Device RL3020-DP0364 in Adult Population With Stable Mild Plaque Psoriasis, Dry Skin and Pruritus
Poland40 participantsStarted 2025-02-27
Plain-language summary
The product RL3020-DP0364 developed by Pierre Fabre Laboratories moisturizes durably and repairs dry or atopic skin, especially in the case of certain dermatoses (atopic dermatitis, ichthyosis, etc ...) and erythema induced by radiotherapy. Its unique formula treats the symptoms of dry skin by creating a protective film that prevents dehydration and helps protect the skin from external aggressions.
Through this study, the efficacy of this medical device will be evaluated specifically in subjects presenting stable psoriasis, dry skin and pruritus with an application on the whole body (excluding the head).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Subject with stable mild plaque psoriasis covering ≤ 10% BSA (Body Surface Area; excluding the head\*)
* Subject whose plaque psoriasis has been diagnosed for at least 6 months before the inclusion visit
* Subject with dry skin according to the investigator assessment
* Subject with a pruritus intensity (on average over the previous 24 hours) ≥ 3 on a Numerical Rating Scale (NRS) between 0 and 10 (with 0 = no pruritus and 10 = worst imaginable pruritus) on the body\*
* the head is not included in the evaluated area
Exclusion criteria:
Criteria related to the disease:
* Subject with erythrodermic psoriasis, pustular psoriasis
* Subject with palmoplantar keratoderma
* Subject with any other aetiology of pruritus, not related to plaque psoriasis
* Subject with history of allergy or intolerance to any of the tested product ingredients
* Subject having any other dermatologic condition than psoriasis, or characteristics (like tattoo, wound…) on body liable to interfere with the study assessments
* Subject having an acute, chronic or progressive disease or history of disease liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
Criteria related to treatments and/or products:
* Biotherapy treatment in the 6 months prior to the inclusion visit or ongoing or planned to be started during the study
* Other systemic treatment for psoriasis (acitretin, cyclosporine, meth…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.