An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy
PAP
1 other identifier
interventional
44
2 countries
29
Brief Summary
To assess the benefit of the Avène hydrotherapy in subjects with pruritic plaque psoriasis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2017
Longer than P75 for not_applicable
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2016
CompletedFirst Posted
Study publicly available on registry
January 18, 2017
CompletedStudy Start
First participant enrolled
March 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2020
CompletedApril 2, 2021
April 1, 2021
3.4 years
October 25, 2016
April 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Pruritus clinical criterion
Pruritus intensity assessed by the subject on the NRS from 0 to 10
Day18
Secondary Outcomes (7)
Pruritus clinical criterion
Day1
Pruritus clinical criterion
Day111
Pruritus clinical criterion
Day202
Psoriasis clinical criterion
Day1, Day18, Day111 and Day202
Quality of life criterion
Day1, Day18, Day111 and Day202
- +2 more secondary outcomes
Study Arms (2)
hydrotherapy group
OTHERSubjects 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 INTERVENTIONSubjects 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).
Interventions
Eligibility Criteria
You may qualify if:
- Subject with plaque psoriasis
- 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
You may not qualify if:
- Subject with erythrodermic psoriasis, pustular psoriasis or palmoplantar keratoderma
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
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
Related Publications (1)
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.
PMID: 37837493DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diana PLACINTESCU, MD
Les Thermes d'Avène
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2016
First Posted
January 18, 2017
Study Start
March 6, 2017
Primary Completion
July 20, 2020
Study Completion
July 20, 2020
Last Updated
April 2, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share