Evaluation of the Efficacy and Tolerance of the Medical Device RL3020-DP0364 in Adult Population With Stable Mild Plaque Psoriasis, Dry Skin and Pruritus

Launched by PIERRE FABRE DERMO COSMETIQUE · Jan 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device called RL3020-DP0364, which is designed to help people with mild plaque psoriasis, dry skin, and itching. The device works by providing long-lasting moisture and creating a protective layer on the skin, helping to prevent dryness and shield the skin from harmful elements. The trial aims to see how effective this device is when applied all over the body, except for the head, in adults who have stable psoriasis.

To participate in the study, individuals need to be adults aged 18 and older with stable mild plaque psoriasis affecting 10% or less of their body (excluding the head) and have experienced moderate to severe itching. Participants should not have other serious skin conditions or have used certain treatments for psoriasis recently. During the trial, those who qualify will apply the device to their skin and help researchers understand how well it works. This study is currently recruiting participants, so if you or someone you know fits the criteria, it might be a great opportunity to contribute to important research while potentially finding relief from symptoms.

Gender

ALL

Eligibility criteria

• 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, methotrexate, apremilast...) in the 3 months prior to the inclusion visit or ongoing or planned to be started during the study
• • Phototherapy treatment in the 4 weeks prior to the inclusion visit or ongoing or planned to be started during the study
• • Any other systemic treatment incompatible with the study or liable to interfere with the study assessments according to the investigator, in the weeks prior to the inclusion visit, ongoing or planned to be started during the study
• • Topical treatment for psoriasis (corticosteroid, vitamin D analogs...) applied on the body\* in the 4 weeks prior to the inclusion visit or ongoing or planned to be started during the study
• • Topical product (including any moisturizer, emollient, keratolytic ...) applied on the body\* in the 7 days prior to the inclusion visit or ongoing or planned to be started during the study
• • Any product applied on the body\* before the visit, the day of inclusion visit
• • Any other topical treatment or product applied on the body\* incompatible with the study or liable to interfere with the study assessments according to the investigator, in the weeks prior to the inclusion visit, ongoing or planned to be started during the study
• • the head is not included in the evaluated area