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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with stable mild plaque psoriasis, dry skin and pruritus | Experimental | Device: Dexeryl (RL3020-DP0364) Tested product is applied twice a day. The maximum duration of application is 30 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexeryl (RL3020-DP0364) | Device | Product application on body (head excluded) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pruritus intensity assessment | The pruritus intensity on the whole body (head excluded) (on average over the previous 24 hours) will be assessed by the subject at Visit 1 (Day 1-before product application) and at Visit 3 (Day 29(±2)) according to the following [0-10] Numerical Rating Scale | 29±2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Average pruritus intensity assessment (previous 24hours) | The pruritus intensity will be assessed on the whole body (head excluded), on average over the previous 24 hours by the subject, according to NRS (Numerical Rating Scale) | Day 1, Day 8, Day 14±2, Day 29±2 |
| Average pruritus intensity assessment (previous 7 days) |
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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*
Exclusion criteria:
Criteria related to the disease:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermscan Poland | Gdansk | Poland | 80288 | Poland |
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The pruritus intensity will be assessed on the whole body (head excluded), on average over the previous 7 days by the subject, according to NRS (Numerical Rating Scale) |
| Day 1, Day 8, Day 14±2, Day 29±2 |
| Worst pruritus intensity assessment (previous 7 days) | The worst pruritus intensity will be assessed on the whole body (head excluded), over the previous 7 days by the subject, according to NRS (Numerical Rating Scale) | Day 1, Day 8, Day 14±2, Day 29±2 |
| Pruritus severity and impact on quality-of-life assessment | pruritus severity and impact on quality of life will be assessed by the subject with a Patient Reported Outcome (PRO) questionnaire including 20 questions | Day 1, Day 14±2, Day 29±2 |
| Pruritus characteristics assessment | Pruritus characteristics (duration, degree, direction, disability and distribution) will be assessed by the subject with a global score (1 global score considering all characteristics) on the 5-D itch scale | Day 1, Day 29±2 |
| mPASI assessment | mPASI (modified Psoriasis Area Severity Index) (excluding the head) will be assessed by the investigator on a scale ranged from 0 to 64,8 | Day 1, Day 14±2, Day 29±2 |
| Xerosis intensity assessment | Xerosis intensity on the whole body outside psoriasis plaques and the xerosis intensity on psoriasis plaques will be assessed by the investigator using the following scale ranged from 0 to 4: 0= None, 1= Mild, 2= Moderate, 3= Severe, 4= Very severe | Day 1, Day 14±2, Day 29±2 |
| Tolerance assessment | Assessment of the tolerance by the investigator with the attribution of one of the 5 levels, considering all individual Adverse Events and their characteristics based on the following 5-point scale (excellent = 5 to bad = 0) | Day 29±2 |
| Acceptability questionnaire assessment | Acceptability questionnaire regarding the use of the product will be completed by the subject | Day 29±2 |
| Illustrative photographs assessment | Photographs of a representative area of psoriasis | Day 1, Day 14±2, Day 29±2 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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