An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy (PAP)

An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy on Chronic Pruritus in Adults With Plaque Psoriasis

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

Study Overview

• Status: Completed
• Conditions: Chronic Pruritus Due to Plaque Psoriasis
• Intervention / Treatment: Other: Hydrotherapy

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)

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • CHU Nord Service de Dermatologie
  • Angers, France
    • CHU Angers Service de Dermatologie
  • Angers, France
    • Dr Martins-Hericher
  • Boulogne-sur-Mer, France
    • CH de Boulogne sur Mer Hôpital DUCHENE - service de dermatologie
  • Brest, France
    • CHU Morvan service de dermatologie
  • Cahors, France
    • Dr Durbise
  • Clisson, France
    • Dr Parant
  • Dunkerque, France
    • Centre Hospitalier de Dunkerque - Service de Dermatologie
  • Langon, France
    • Dr Abbadie
  • Lavaur, France
    • Dr Durieu
  • Limoges, France
    • Dr Orsoni
  • Lingolsheim, France
    • Dr Gutmann Heller
  • Lorient, France
    • Dr Foucault
  • Marseille, France
    • Dr Nicol
  • Martigues, France
    • Dr Ruer-Mulard
  • Montpellier, France
    • Hôpital St Eloi Service de Dermatologie
  • Mulhouse, France
    • GHRMSA Hôpital Emile Muller Service de Dermatologie
  • Nantes, France
    • CHU Nantes - Unité Dermato-Cancérologie 7° nord Hotel Dieu
  • Nice, 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
  • Obernai, France
    • Dr Fritsch
  • Paris, France
    • Dr Pfister
  • Poitiers, France
    • CHU de Poitiers Pole régional de cancérologie Service de dermatologie
  • Saint-Germain-en-Laye, France
    • Centre hospitalier Poissy St germain
  • Toulouse, France
    • Dr Gadroy
  • Tours, France
    • CHRU Tours Service de Dermatologie
  • Tours, France
    • Dr Abdo-Morales
• Spain
  • Barcelona, Spain
    • Hospital de la Santa Creu i Sant Pau Dept. of Dermatology
  • Girona, Spain
    • Hospital Santa Caterina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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).	Other: Hydrotherapy; 3-week Avène hydrotherapy
No Intervention: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pruritus clinical criterion	Pruritus intensity assessed by the subject on the NRS from 0 to 10	Day18

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pierre Fabre Dermo Cosmetique
• Investigators: Principal Investigator: Diana PLACINTESCU, MD, Les Thermes d'Avène

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2017
• Primary Completion (Actual): July 20, 2020
• Study Completion (Actual): July 20, 2020

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: January 13, 2017
• First Posted (Estimate): January 18, 2017

Study Record Updates

• Last Update Posted (Actual): April 2, 2021
• Last Update Submitted That Met QC Criteria: April 1, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Skin Manifestations; Psoriasis; Pruritus
• Other Study ID Numbers: PAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No