PsoriasisNCT06800755
Evaluation of the Efficacy and Tolerance of the Medical Device RL3020-DP0364 in Adult Population With Stable Mild Plaque Psoriasis, Dry Skin and Pruritus
A study testing Dexeryl (RL3020-DP0364) in people with Psoriasis and Pruritus, run by Pierre Fabre Dermo Cosmetique at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Dexeryl (RL3020-DP0364)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 27 Feb 2025to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Being tested
- Dexeryl (RL3020-DP0364)
- Keywords
- Psoriasis, Pruritus, Dry Skin, Medical Device
- Medical subject headings
- Psoriasis, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexeryl (RL3020-DP0364)Device
Product application on body (head excluded)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Dexeryl (RL3020-DP0364) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 29±2 days
Secondary outcomes (10)
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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Day 29±2
Acceptability questionnaire assessment
Acceptability questionnaire regarding the use of the product will be completed by the subject
Measured: Day 29±2
Illustrative photographs assessment
Photographs of a representative area of psoriasis
Measured: Day 1, Day 14±2, Day 29±2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start27 Feb 2025
- Primary completion10 Jul 2025
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800755
- Sponsor's protocol ID
- RL302020240210
- Status last verified
- May 2026
- First submitted
- 24 Jan 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Tolerance of the Medical Device RL3020-DP0364 in Adult Population With Stable Mild Plaque Psoriasis, Dry Skin and Pruritus
- ClinicalTrials.gov ID
- NCT06800755
- Acronym / sponsor ID
- RL302020240210
- Keywords
- Psoriasis, Pruritus, Dry Skin, Medical Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with stable mild plaque psoriasis, dry skin and pruritus | Experimental | Device: Dexeryl (RL3020-DP0364)Device: Dexeryl (RL3020-DP0364) Tested product is applied twice a day. The maximum duration of application is 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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*
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexeryl (RL3020-DP0364)Product application on body (head excluded) | Device | Adults with stable mild plaque psoriasis, dry skin and pruritus |
Primary outcome
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
10 secondary outcomes
Average pruritus intensity assessment (previous 24hours)
Time frame: Day 1, Day 8, Day 14±2, Day 29±2
Average pruritus intensity assessment (previous 7 days)
Time frame: Day 1, Day 8, Day 14±2, Day 29±2
Worst pruritus intensity assessment (previous 7 days)
Time frame: Day 1, Day 8, Day 14±2, Day 29±2
Pruritus severity and impact on quality-of-life assessment
Time frame: Day 1, Day 14±2, Day 29±2
Pruritus characteristics assessment
Time frame: Day 1, Day 29±2
mPASI assessment
Time frame: Day 1, Day 14±2, Day 29±2
Xerosis intensity assessment
Time frame: Day 1, Day 14±2, Day 29±2
Tolerance assessment
Time frame: Day 29±2
Acceptability questionnaire assessment
Time frame: Day 29±2
Illustrative photographs assessment
Time frame: Day 1, Day 14±2, Day 29±2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexeryl (RL3020-DP0364) in people with Psoriasis and Pruritus, run by Pierre Fabre Dermo Cosmetique at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pruritus intensity assessment (time frame: 29±2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.