Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the benefit of the Avène hydrotherapy in subjects with pruritic plaque psoriasis
To assess the benefit of the Avène hydrotherapy in subjects with pruritic plaque psoriasis in the:
To assess the time to pruritus relapse evaluated in subjects with pruritic plaque psoriasis, during the period following the Avène hydrotherapy (for the hydrotherapy group only)
To assess the global efficacy of the Avène hydrotherapy in pruritic plaque psoriasis, according to subjects' and investigators' opinion (for the hydrotherapy group only)
To assess the global cutaneous tolerance of the Avène hydrotherapy in subjects with pruritic plaque psoriasis (for the hydrotherapy group only)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hydrotherapy group | Other | Subjects included in the "hydrotherapy group" will undergo a 3-week Avène hydrotherapy in addition to their usual psoriasis and/or pruritus management (treatments and/or skin care products). |
|
| Control group | No Intervention | Subjects included in the "control group" will not undergo the hydrotherapy and will keep following their usual psoriasis and/or pruritus management (treatments and/or skin care products). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrotherapy | Other | 3-week Avène hydrotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pruritus clinical criterion | Pruritus intensity assessed by the subject on the NRS from 0 to 10 | Day18 |
| Measure | Description | Time Frame |
|---|---|---|
| Pruritus clinical criterion | Pruritus intensity assessed by the subject on the NRS from 0 to 10 | Day1 |
| Pruritus clinical criterion | Pruritus intensity assessed by the subject on the NRS from 0 to 10 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Diana PLACINTESCU, MD | Les Thermes d'Avène | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nord Service de Dermatologie | Amiens | France | ||||
| CHU Angers Service de Dermatologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37837493 | Derived | Thouvenin MD, Bacquey A, Babin M, Lestienne F, Lauze C, Gravier E, Placintescu D, Ortiz-Brugues A, Stander S. Efficacy of Avene Hydrotherapy on Chronic Pruritus in Patients with Plaque Psoriasis. Dermatol Ther (Heidelb). 2023 Dec;13(12):3137-3151. doi: 10.1007/s13555-023-01047-2. Epub 2023 Oct 14. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Day111 |
| Pruritus clinical criterion | Pruritus intensity assessed by the subject on the NRS from 0 to 10 | Day202 |
| Psoriasis clinical criterion | Psoriasis Area Severity Index assessed by the investigator on a scale ranged from 0 to 72 | Day1, Day18, Day111 and Day202 |
| Quality of life criterion | ItchyQoL questionnaire | Day1, Day18, Day111 and Day202 |
| Biological criterion (markers linked to neurogenic inflammation, epidermal differentiation, inflammation, antimicrobial peptides) | Psoriasis and pruritus biological markers | Day1, Day18, Day111 and Day202 |
| Hydrotherapy criterion | Hydrotherapy global cutaneous tolerance on 4-point scale (0 = No effective ; 1=Little effective ; 2=Effective and 3=Very effective) | Day18 |
| Angers |
| France |
| Dr Martins-Hericher | Angers | France |
| CH de Boulogne sur Mer Hôpital DUCHENE - service de dermatologie | Boulogne-sur-Mer | France |
| CHU Morvan service de dermatologie | Brest | France |
| Dr Durbise | Cahors | France |
| Dr Parant | Clisson | France |
| Centre Hospitalier de Dunkerque - Service de Dermatologie | Dunkirk | France |
| Dr Abbadie | Langon | France |
| Dr Durieu | Lavaur | France |
| Dr Orsoni | Limoges | France |
| Dr Gutmann Heller | Lingolsheim | France |
| Dr Foucault | Lorient | France |
| Dr Nicol | Marseille | France |
| Dr Ruer-Mulard | Martigues | France |
| Hôpital St Eloi Service de Dermatologie | Montpellier | France |
| GHRMSA Hôpital Emile Muller Service de Dermatologie | Mulhouse | France |
| CHU Nantes - Unité Dermato-Cancérologie 7° nord Hotel Dieu | Nantes | France |
| Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) - Hôpital l'Archet 2 | Nice | France |
| CHU Nice - Hôpital l'Archet 1 - Centre de recherche clinique | Nice | France |
| Dr Fritsch | Obernai | France |
| Dr Pfister | Paris | France |
| CHU de Poitiers Pole régional de cancérologie Service de dermatologie | Poitiers | France |
| Centre hospitalier Poissy St germain | Saint-Germain-en-Laye | France |
| Dr Gadroy | Toulouse | France |
| CHRU Tours Service de Dermatologie | Tours | France |
| Dr Abdo-Morales | Tours | France |
| Hospital de la Santa Creu i Sant Pau Dept. of Dermatology | Barcelona | Spain |
| Hospital Santa Caterina | Girona | Spain |
| ID | Term |
|---|---|
| D006875 | Hydrotherapy |
| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
Not provided
Not provided