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

NCT06800755 | Completed DMC

• 1 other identifier: RL302020240210
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Psoriasis; Pruritus; Dry Skin

Keywords

Psoriasis; Pruritus; Dry Skin; Medical Device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Average pruritus intensity assessment (previous 24hours)

  Day 1, Day 8, Day 14±2, Day 29±2

• Average pruritus intensity assessment (previous 7 days)

  Day 1, Day 8, Day 14±2, Day 29±2

• Worst pruritus intensity assessment (previous 7 days)

  Day 1, Day 8, Day 14±2, Day 29±2

• Pruritus severity and impact on quality-of-life assessment

  Day 1, Day 14±2, Day 29±2

• Pruritus characteristics assessment

  Day 1, Day 29±2

Study Arms (1)

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.

Device: Dexeryl (RL3020-DP0364)

Interventions

Dexeryl (RL3020-DP0364) DEVICE

Product application on body (head excluded)

Adults with stable mild plaque psoriasis, dry skin and pruritus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with stable mild plaque psoriasis covering ≤ 10% BSA (Body Surface Area; excluding the head\*)
• 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

You may not qualify if:

• 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:
• the head is not included in the evaluated area

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Dermscan Poland

Gdansk, Poland, 80288, Poland

Location

MeSH Terms

Conditions

Psoriasis; Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: February 27, 2025
• Primary Completion: July 10, 2025
• Study Completion: July 10, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

PL (1)