Clinical trial NCT06800755: Evaluation of the Efficacy and Tolerance of the Medical Device RL3020-DP0364 in Adult Population With Stable Mild Plaque Psoriasis, Dry Skin and Pruritus
Official title: Evaluation of the Efficacy and Tolerance of the Medical Device RL3020-DP0364 in Adult Population With Stable Mild Plaque Psoriasis, Dry Skin and Pruritus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psoriasis
Pruritus
Dry Skin
Keywords: Psoriasis
Pruritus
Dry Skin
Medical Device
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
First posted: 2025-01-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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).


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

Primary outcomes:
measure: Pruritus intensity assessment
timeFrame: 29±2 days
Secondary outcomes:
measure: Average pruritus intensity assessment (previous 24hours)
timeFrame: Day 1, Day 8, Day 14±2, Day 29±2
measure: Average pruritus intensity assessment (previous 7 days)
timeFrame: Day 1, Day 8, Day 14±2, Day 29±2
measure: Worst pruritus intensity assessment (previous 7 days)
timeFrame: Day 1, Day 8, Day 14±2, Day 29±2
measure: Pruritus severity and impact on quality-of-life assessment
timeFrame: Day 1, Day 14±2, Day 29±2
measure: Pruritus characteristics assessment
timeFrame: Day 1, Day 29±2
measure: mPASI assessment
timeFrame: Day 1, Day 14±2, Day 29±2
measure: Xerosis intensity assessment
timeFrame: Day 1, Day 14±2, Day 29±2
measure: Tolerance assessment
timeFrame: Day 29±2
measure: Acceptability questionnaire assessment
timeFrame: Day 29±2
measure: Illustrative photographs assessment
timeFrame: Day 1, Day 14±2, Day 29±2
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Dermscan Poland
Study officials:
References: