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

Primary Purpose

Chronic Pruritus Due to Plaque Psoriasis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Hydrotherapy
Sponsored by
Pierre Fabre Dermo Cosmetique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pruritus Due to Plaque Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Nord Service de Dermatologie
  • CHU Angers Service de Dermatologie
  • Dr Martins-Hericher
  • CH de Boulogne sur Mer Hôpital DUCHENE - service de dermatologie
  • CHU Morvan service de dermatologie
  • Dr Durbise
  • Dr Parant
  • Centre Hospitalier de Dunkerque - Service de Dermatologie
  • Dr Abbadie
  • Dr Durieu
  • Dr Orsoni
  • Dr Gutmann Heller
  • Dr Foucault
  • Dr Nicol
  • Dr Ruer-Mulard
  • Hôpital St Eloi Service de Dermatologie
  • GHRMSA Hôpital Emile Muller Service de Dermatologie
  • CHU Nantes - Unité Dermato-Cancérologie 7° nord Hotel Dieu
  • Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) - Hôpital l'Archet 2
  • CHU Nice - Hôpital l'Archet 1 - Centre de recherche clinique
  • Dr Fritsch
  • Dr Pfister
  • CHU de Poitiers Pole régional de cancérologie Service de dermatologie
  • Centre hospitalier Poissy St germain
  • Dr Gadroy
  • CHRU Tours Service de Dermatologie
  • Dr Abdo-Morales
  • Hospital de la Santa Creu i Sant Pau Dept. of Dermatology
  • Hospital Santa Caterina

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

hydrotherapy group

Control group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Pruritus clinical criterion
Pruritus intensity assessed by the subject on the NRS from 0 to 10

Secondary Outcome Measures

Pruritus clinical criterion
Pruritus intensity assessed by the subject on the NRS from 0 to 10
Pruritus clinical criterion
Pruritus intensity assessed by the subject on the NRS from 0 to 10
Pruritus clinical criterion
Pruritus intensity assessed by the subject on the NRS from 0 to 10
Psoriasis clinical criterion
Psoriasis Area Severity Index assessed by the investigator on a scale ranged from 0 to 72
Quality of life criterion
ItchyQoL questionnaire
Biological criterion (markers linked to neurogenic inflammation, epidermal differentiation, inflammation, antimicrobial peptides)
Psoriasis and pruritus biological markers
Hydrotherapy criterion
Hydrotherapy global cutaneous tolerance on 4-point scale (0 = No effective ; 1=Little effective ; 2=Effective and 3=Very effective)

Full Information

First Posted
October 25, 2016
Last Updated
April 1, 2021
Sponsor
Pierre Fabre Dermo Cosmetique
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1. Study Identification

Unique Protocol Identification Number
NCT03023254
Brief Title
An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy
Acronym
PAP
Official Title
An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy on Chronic Pruritus in Adults With Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 6, 2017 (Actual)
Primary Completion Date
July 20, 2020 (Actual)
Study Completion Date
July 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pierre Fabre Dermo Cosmetique

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pruritus Due to Plaque Psoriasis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hydrotherapy group
Arm Type
Other
Arm Description
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).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Hydrotherapy
Intervention Description
3-week Avène hydrotherapy
Primary Outcome Measure Information:
Title
Pruritus clinical criterion
Description
Pruritus intensity assessed by the subject on the NRS from 0 to 10
Time Frame
Day18
Secondary Outcome Measure Information:
Title
Pruritus clinical criterion
Description
Pruritus intensity assessed by the subject on the NRS from 0 to 10
Time Frame
Day1
Title
Pruritus clinical criterion
Description
Pruritus intensity assessed by the subject on the NRS from 0 to 10
Time Frame
Day111
Title
Pruritus clinical criterion
Description
Pruritus intensity assessed by the subject on the NRS from 0 to 10
Time Frame
Day202
Title
Psoriasis clinical criterion
Description
Psoriasis Area Severity Index assessed by the investigator on a scale ranged from 0 to 72
Time Frame
Day1, Day18, Day111 and Day202
Title
Quality of life criterion
Description
ItchyQoL questionnaire
Time Frame
Day1, Day18, Day111 and Day202
Title
Biological criterion (markers linked to neurogenic inflammation, epidermal differentiation, inflammation, antimicrobial peptides)
Description
Psoriasis and pruritus biological markers
Time Frame
Day1, Day18, Day111 and Day202
Title
Hydrotherapy criterion
Description
Hydrotherapy global cutaneous tolerance on 4-point scale (0 = No effective ; 1=Little effective ; 2=Effective and 3=Very effective)
Time Frame
Day18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana PLACINTESCU, MD
Organizational Affiliation
Les Thermes d'Avène
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Nord Service de Dermatologie
City
Amiens
Country
France
Facility Name
CHU Angers Service de Dermatologie
City
Angers
Country
France
Facility Name
Dr Martins-Hericher
City
Angers
Country
France
Facility Name
CH de Boulogne sur Mer Hôpital DUCHENE - service de dermatologie
City
Boulogne-sur-Mer
Country
France
Facility Name
CHU Morvan service de dermatologie
City
Brest
Country
France
Facility Name
Dr Durbise
City
Cahors
Country
France
Facility Name
Dr Parant
City
Clisson
Country
France
Facility Name
Centre Hospitalier de Dunkerque - Service de Dermatologie
City
Dunkerque
Country
France
Facility Name
Dr Abbadie
City
Langon
Country
France
Facility Name
Dr Durieu
City
Lavaur
Country
France
Facility Name
Dr Orsoni
City
Limoges
Country
France
Facility Name
Dr Gutmann Heller
City
Lingolsheim
Country
France
Facility Name
Dr Foucault
City
Lorient
Country
France
Facility Name
Dr Nicol
City
Marseille
Country
France
Facility Name
Dr Ruer-Mulard
City
Martigues
Country
France
Facility Name
Hôpital St Eloi Service de Dermatologie
City
Montpellier
Country
France
Facility Name
GHRMSA Hôpital Emile Muller Service de Dermatologie
City
Mulhouse
Country
France
Facility Name
CHU Nantes - Unité Dermato-Cancérologie 7° nord Hotel Dieu
City
Nantes
Country
France
Facility Name
Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) - Hôpital l'Archet 2
City
Nice
Country
France
Facility Name
CHU Nice - Hôpital l'Archet 1 - Centre de recherche clinique
City
Nice
Country
France
Facility Name
Dr Fritsch
City
Obernai
Country
France
Facility Name
Dr Pfister
City
Paris
Country
France
Facility Name
CHU de Poitiers Pole régional de cancérologie Service de dermatologie
City
Poitiers
Country
France
Facility Name
Centre hospitalier Poissy St germain
City
Saint-Germain-en-Laye
Country
France
Facility Name
Dr Gadroy
City
Toulouse
Country
France
Facility Name
CHRU Tours Service de Dermatologie
City
Tours
Country
France
Facility Name
Dr Abdo-Morales
City
Tours
Country
France
Facility Name
Hospital de la Santa Creu i Sant Pau Dept. of Dermatology
City
Barcelona
Country
Spain
Facility Name
Hospital Santa Caterina
City
Girona
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy

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