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

Pierre Fabre

Status

Enrolling

Conditions

Psoriasis

Dry Skin

Pruritus

Treatments

Device: Dexeryl (RL3020-DP0364)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06800755

RL302020240210

Details and patient eligibility

About

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).

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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