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

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 Overview

• Status: Completed
• Conditions: Psoriasis; Pruritus; Dry Skin
• Intervention / Treatment: Device: Dexeryl (RL3020-DP0364)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Poland
    • Gdansk, Poland, Poland, 80288
      • Dermscan Poland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adults with stable mild plaque psoriasis, dry skin and pruritus; Device: Dexeryl (RL3020-DP0364) Tested product is applied twice a day. The maximum duration of application is 30 days.	Device: Dexeryl (RL3020-DP0364); Product application on body (head excluded)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Pierre Fabre Dermo Cosmetique

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2025
• Primary Completion (Actual): July 10, 2025
• Study Completion (Actual): July 10, 2025

Study Registration Dates

• First Submitted: January 24, 2025
• First Submitted That Met QC Criteria: January 24, 2025
• First Posted (Actual): January 30, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Psoriasis; Pruritus; Medical Device; Dry Skin
• Additional Relevant MeSH Terms: Skin Manifestations; Skin Diseases, Papulosquamous; Skin Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Psoriasis; Pruritus
• Other Study ID Numbers: RL302020240210

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No