An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy
NCT ID: NCT03023254
Last Updated: 2021-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2017-03-06
2020-07-20
Brief Summary
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Detailed Description
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* Improvement of pruritus
* Improvement of psoriasis severity
* Improvement of quality of life
* Change of pruritus and psoriasis biological markers
* Intake/application of treatments and skin care products for psoriasis and pruritus management, evaluated during a follow-up period
* 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)
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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hydrotherapy group
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).
Hydrotherapy
3-week Avène hydrotherapy
Control group
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).
No interventions assigned to this group
Interventions
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Hydrotherapy
3-week Avène hydrotherapy
Eligibility Criteria
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Inclusion Criteria
* Subject with moderate to very severe chronic pruritus whose NRS score ≥ 4, (on a scale ranged from 0 to 10)
* Subject with chronic pruritus, i.e. for at least 6 weeks, due to plaque psoriasis
Exclusion Criteria
* Subject with any other type of pruritus, not related to plaque psoriasis
* Subject with an acute, chronic or progressive disease other than plaque psoriasis which could be the origin of the pruritus
* Biotherapy, Phototherapy or PUVAtherapy treatment
* Psoriasis treatment by LASER
* Systemic or topical treatment taken/applied for psoriasis or pruritus management established or modified since the selection visit or planned to be established or modified between the inclusion visit and the end of the hydrotherapy
18 Years
ALL
No
Sponsors
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Pierre Fabre Dermo Cosmetique
INDUSTRY
Responsible Party
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Principal Investigators
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Diana PLACINTESCU, MD
Role: PRINCIPAL_INVESTIGATOR
Les Thermes d'Avène
Locations
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CHU Nord Service de Dermatologie
Amiens, , France
CHU Angers Service de Dermatologie
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
Countries
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References
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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.
Other Identifiers
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PAP
Identifier Type: -
Identifier Source: org_study_id
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