NCT06800755Befejeződött
Evaluation of the Efficacy and Tolerance of the Medical Device RL3020-DP0364 in Adult Population With Stable Mild Plaque Psoriasis, Dry Skin and Pruritus
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 5.
Rövid összefoglaló (regiszter, angolul)
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).
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 40 (tényleges)
- Első benyújtás
- 2025. jan. 24.
- Kezdés
- 2025. febr. 27.
- Elsődleges befejezés
- 2025. júl. 10.
- Fő szponzor
- Pierre Fabre Dermo Cosmetique
- Betegségek
- Pikkelysömör
- NCT-szám
- NCT06800755
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 40
- 2025. febr. 27. és az elsődleges befejezés (2025. júl. 10.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- 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 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
Más betegség
- Criteria related to the disease:
- 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:
Egyéb
- Subject with erythrodermic psoriasis, pustular psoriasis
- Subject with palmoplantar keratoderma
- Subject with any other aetiology of pruritus, not related to plaque psoriasis
- Any product applied on the body* before the visit, the day of inclusion visit
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Dermscan Poland | Gdansk | Lengyelország | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.