Evaluating a medical device for treating mild plaque psoriasis and dry skin
Evaluation of the Efficacy and Tolerance of the Medical Device RL3020-DP0364 in Adult Population With Stable Mild Plaque Psoriasis, Dry Skin and Pruritus
This study is testing a new device to see if it can help adults with mild plaque psoriasis and dry skin feel better by moisturizing and protecting their skin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pierre Fabre Dermo Cosmetique Industry-sponsored |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Gdańsk) |
| Trial ID | NCT06800755 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and tolerance of the medical device RL3020-DP0364 in adults with stable mild plaque psoriasis, dry skin, and pruritus. The device is designed to moisturize and repair dry skin by creating a protective film that prevents dehydration and shields the skin from external aggressors. Participants will apply the device over their entire body, excluding the head, to assess its effectiveness in alleviating symptoms associated with their skin condition.
Who should consider this trial
Good fit: Ideal candidates are adults with stable mild plaque psoriasis covering 10% or less of their body surface area, along with dry skin and moderate pruritus.
Not a fit: Patients with severe forms of psoriasis, such as erythrodermic or pustular psoriasis, or those with other dermatological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve skin hydration and reduce discomfort for patients with mild plaque psoriasis.
How similar studies have performed: While this specific approach is novel, similar studies evaluating moisturizing devices for skin conditions have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Gdańsk
- Dermscan Poland — Gdańsk, Poland (Recruiting)
Study contacts
- Study coordinator: Adeline Bacquey
- Email: adeline.bacquey@pierre-fabre.com
- Phone: +33562877753
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.