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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
Product application on body (head excluded)
Dermscan Poland
Gdansk, Poland, Poland
RECRUITINGPruritus 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
Time frame: 29±2 days
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)
Time frame: Day 1, Day 8, Day 14±2, Day 29±2
Average pruritus intensity assessment (previous 7 days)
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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Day 29±2
Acceptability questionnaire assessment
Acceptability questionnaire regarding the use of the product will be completed by the subject
Time frame: Day 29±2
Illustrative photographs assessment
Photographs of a representative area of psoriasis
Time frame: Day 1, Day 14±2, Day 29±2
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