Clinical trial NCT03023254: An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy
Official title: An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy on Chronic Pruritus in Adults With Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pruritus Due to Plaque Psoriasis
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
First posted: 2017-01-18
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To assess the benefit of the Avène hydrotherapy in subjects with pruritic plaque psoriasis

Detailed description: * To assess the benefit of the Avène hydrotherapy in subjects with pruritic plaque psoriasis in the:

  * 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)

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Pruritus clinical criterion
timeFrame: Day18
Secondary outcomes:
measure: Pruritus clinical criterion
timeFrame: Day1
measure: Pruritus clinical criterion
timeFrame: Day111
measure: Pruritus clinical criterion
timeFrame: Day202
measure: Psoriasis clinical criterion
timeFrame: Day1, Day18, Day111 and Day202
measure: Quality of life criterion
timeFrame: Day1, Day18, Day111 and Day202
measure: Biological criterion (markers linked to neurogenic inflammation, epidermal differentiation, inflammation, antimicrobial peptides)
timeFrame: Day1, Day18, Day111 and Day202
measure: Hydrotherapy criterion
timeFrame: Day18
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Nord Service de Dermatologie
city: Angers
country: France
facility: CHU Angers Service de Dermatologie
city: Angers
country: France
facility: Dr Martins-Hericher
city: Boulogne-sur-Mer
country: France
facility: CH de Boulogne sur Mer Hôpital DUCHENE - service de dermatologie
city: Brest
country: France
facility: CHU Morvan service de dermatologie
city: Cahors
country: France
facility: Dr Durbise
city: Clisson
country: France
facility: Dr Parant
city: Dunkerque
country: France
facility: Centre Hospitalier de Dunkerque - Service de Dermatologie
city: Langon
country: France
facility: Dr Abbadie
city: Lavaur
country: France
facility: Dr Durieu
city: Limoges
country: France
facility: Dr Orsoni
city: Lingolsheim
country: France
facility: Dr Gutmann Heller
city: Lorient
country: France
facility: Dr Foucault
city: Marseille
country: France
facility: Dr Nicol
city: Martigues
country: France
facility: Dr Ruer-Mulard
city: Montpellier
country: France
facility: Hôpital St Eloi Service de Dermatologie
city: Mulhouse
country: France
facility: GHRMSA Hôpital Emile Muller Service de Dermatologie
city: Nantes
country: France
facility: CHU Nantes - Unité Dermato-Cancérologie 7° nord Hotel Dieu
city: Nice
country: France
facility: Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) - Hôpital l'Archet 2
city: Nice
country: France
facility: CHU Nice - Hôpital l'Archet 1 - Centre de recherche clinique
city: Obernai
country: France
facility: Dr Fritsch
city: Paris
country: France
facility: Dr Pfister
city: Poitiers
country: France
facility: CHU de Poitiers Pole régional de cancérologie Service de dermatologie
city: Saint-Germain-en-Laye
country: France
facility: Centre hospitalier Poissy St germain
city: Toulouse
country: France
facility: Dr Gadroy
city: Tours
country: France
facility: CHRU Tours Service de Dermatologie
city: Tours
country: France
facility: Dr Abdo-Morales
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau Dept. of Dermatology
city: Girona
country: Spain
facility: Hospital Santa Caterina
Study officials:
affiliation: Les Thermes d'Avène
name: Diana PLACINTESCU, MD
role: PRINCIPAL_INVESTIGATOR
References: