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Completed

NCT Number: NCT06800755

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).

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Key information

Conditions

Psoriasis Dry Skin Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Papulosquamous Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermscan Poland

Gdansk, Poland, 80288

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexeryl (RL3020-DP0364)

Device

Product application on body (head excluded)

Primary outcomes

  1. Pruritus intensity assessment

    Time frame: 29±2 days

    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

Secondary outcomes

  1. Average pruritus intensity assessment (previous 24hours)

    Time frame: Day 1, Day 8, Day 14±2, Day 29±2

    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)

  2. Average pruritus intensity assessment (previous 7 days)

    Time frame: Day 1, Day 8, Day 14±2, Day 29±2

    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)

  3. Worst pruritus intensity assessment (previous 7 days)

    Time frame: Day 1, Day 8, Day 14±2, Day 29±2

    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)

  4. Pruritus severity and impact on quality-of-life assessment

    Time frame: Day 1, Day 14±2, Day 29±2

    pruritus severity and impact on quality of life will be assessed by the subject with a Patient Reported Outcome (PRO) questionnaire including 20 questions

  5. Pruritus characteristics assessment

    Time frame: Day 1, Day 29±2

    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

  6. mPASI assessment

    Time frame: Day 1, Day 14±2, Day 29±2

    mPASI (modified Psoriasis Area Severity Index) (excluding the head) will be assessed by the investigator on a scale ranged from 0 to 64,8

  7. Xerosis intensity assessment

    Time frame: Day 1, Day 14±2, Day 29±2

    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

  8. Tolerance assessment

    Time frame: Day 29±2

    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)

  9. Acceptability questionnaire assessment

    Time frame: Day 29±2

    Acceptability questionnaire regarding the use of the product will be completed by the subject

  10. Illustrative photographs assessment

    Time frame: Day 1, Day 14±2, Day 29±2

    Photographs of a representative area of psoriasis

Sponsors and collaborators

Lead sponsor

Pierre Fabre Dermo Cosmetique

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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