An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03023254
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pierre Fabre Dermo Cosmetique
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Diana PLACINTESCU, MD
Principal Investigator Affiliation Les Thermes d'Avène
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries France, Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Chronic Pruritus Due to Plaque Psoriasis
Additional Details

- 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)

Arms & Interventions

Arms

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).

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).

Interventions

Other: - Hydrotherapy

3-week Avène hydrotherapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU Nord Service de Dermatologie, Amiens, France

Status

Not yet recruiting

Address

CHU Nord Service de Dermatologie

Amiens, ,

Site Contact

Ali DADBAN, Dr

[email protected]

+33562877753

Dr Carmi, Amiens, France

Status

Withdrawn

Address

Dr Carmi

Amiens, ,

CHU Angers Service de Dermatologie, Angers, France

Status

Recruiting

Address

CHU Angers Service de Dermatologie

Angers, ,

Site Contact

Juliette DELAUNAY, Dr

[email protected]

+33562877753

Dr Martins-Hericher, Angers, France

Status

Not yet recruiting

Address

Dr Martins-Hericher

Angers, ,

Site Contact

Joana Martins-Hericher, Dr

[email protected]

+33562877753

Centre Hospitalier de la côte Basque, Bayonne, France

Status

Withdrawn

Address

Centre Hospitalier de la côte Basque

Bayonne, ,

Besançon, France

Status

Withdrawn

Address

CHU Jean Minjoz - Service de Dermatologie

Besançon, ,

Boulogne-sur-Mer, France

Status

Recruiting

Address

CH de Boulogne sur Mer Hôpital DUCHENE - service de dermatologie

Boulogne-sur-Mer, ,

Site Contact

Sophie DARRAS, Dr

[email protected]

+33562877753

CHU Morvan service de dermatologie, Brest, France

Status

Recruiting

Address

CHU Morvan service de dermatologie

Brest, ,

Site Contact

Laurent MISERY, Pr

[email protected]

+33562877753

Dr Durbise, Cahors, France

Status

Recruiting

Address

Dr Durbise

Cahors, ,

Site Contact

Elizabeth Durbise, Dr

[email protected]

+33562877753

Dr Parant, Clisson, France

Status

Not yet recruiting

Address

Dr Parant

Clisson, ,

Site Contact

Emmanuel Parant, Dr

[email protected]

+33562877753

Dunkerque, France

Status

Completed

Address

Centre Hospitalier de Dunkerque - Service de Dermatologie

Dunkerque, ,

Dr Horreau, Gardanne, France

Status

Withdrawn

Address

Dr Horreau

Gardanne, ,

Dr Abbadie, Langon, France

Status

Recruiting

Address

Dr Abbadie

Langon, ,

Site Contact

Dominique Abbadie, Dr

[email protected]

+33562877753

Dr Durieu, Lavaur, France

Status

Recruiting

Address

Dr Durieu

Lavaur, ,

Site Contact

Christelle Durieu, Dr

[email protected]

+33562877753

CH Le Mans - Service de Dermatologie, Le Mans, France

Status

Withdrawn

Address

CH Le Mans - Service de Dermatologie

Le Mans, ,

Dr Robbiola, Limeil-Brévannes, France

Status

Withdrawn

Address

Dr Robbiola

Limeil-Brévannes, ,

Dr Orsoni, Limoges, France

Status

Recruiting

Address

Dr Orsoni

Limoges, ,

Site Contact

Dominique Orsoni, Dr

[email protected]

+33562877753

Dr Gutmann Heller, Lingolsheim, France

Status

Recruiting

Address

Dr Gutmann Heller

Lingolsheim, ,

Site Contact

Agnès Gutmann Heller, Dr

[email protected]

+33562877753

Dr Foucault, Lorient, France

Status

Recruiting

Address

Dr Foucault

Lorient, ,

Site Contact

Vincent Foucault, Dr

[email protected]

+33562877753

Mantes-la-Jolie, France

Status

Withdrawn

Address

CH Mantes la Jolie - Service de Dermatologie

Mantes-la-Jolie, ,

Dr Nicol, Marseille, France

Status

Recruiting

Address

Dr Nicol

Marseille, ,

Site Contact

Isabelle Nicol, Dr

[email protected]

+33562877753

Dr Ruer-Mulard, Martigues, France

Status

Recruiting

Address

Dr Ruer-Mulard

Martigues, ,

Site Contact

Mireille Ruer-Mulard, Dr

[email protected]

+33562877753

Hôpital St Eloi Service de Dermatologie, Montpellier, France

Status

Recruiting

Address

Hôpital St Eloi Service de Dermatologie

Montpellier, ,

Site Contact

Céline GIRARD, Dr

[email protected]

+33562877753

Mulhouse, France

Status

Recruiting

Address

GHRMSA Hôpital Emile Muller Service de Dermatologie

Mulhouse, ,

Site Contact

Catherine MICHEL, Dr

[email protected]

+33562877753

Nantes, France

Status

Not yet recruiting

Address

CHU Nantes - Unité Dermato-Cancérologie 7° nord Hotel Dieu

Nantes, ,

Site Contact

Brigitte DRENO, Dr

[email protected]

+33562877753

Nice, France

Status

Not yet recruiting

Address

Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) - Hôpital l'Archet 2

Nice, ,

Site Contact

Catherine Queille Roussel, Dr

[email protected]

+33562877753

Nice, France

Status

Recruiting

Address

CHU Nice - Hôpital l'Archet 1 - Centre de recherche clinique

Nice, ,

Site Contact

Florence Le Duff, Dr

[email protected]

+33562877753

Dr Joganah, Niederbronn-les-Bains, France

Status

Withdrawn

Address

Dr Joganah

Niederbronn-les-Bains, ,

Dr Fritsch, Obernai, France

Status

Recruiting

Address

Dr Fritsch

Obernai, ,

Site Contact

Christine Fritsch, Dr

[email protected]

+33562877753

Dr Pfister, Paris, France

Status

Recruiting

Address

Dr Pfister

Paris, ,

Site Contact

Pierre Pfister, Dr

[email protected]

+33562877753

Poitiers, France

Status

Recruiting

Address

CHU de Poitiers Pole régional de cancérologie Service de dermatologie

Poitiers, ,

Site Contact

Eva WIERZBICKA-HAINAUT, Dr

[email protected]

+33562877753

Rouen, France

Status

Withdrawn

Address

CHU de Rouen - Hôpital Charles Nicolle - Clinique Dermatologique

Rouen, ,

Centre hospitalier Poissy St germain, Saint-Germain-en-Laye, France

Status

Not yet recruiting

Address

Centre hospitalier Poissy St germain

Saint-Germain-en-Laye, ,

Site Contact

Domitille THOMAS-BEAULIEU, Dr

[email protected]

+33562877753

Dr Dupont, Saint-Pol-sur-Mer, France

Status

Withdrawn

Address

Dr Dupont

Saint-Pol-sur-Mer, ,

Dr Gadroy, Toulouse, France

Status

Recruiting

Address

Dr Gadroy

Toulouse, ,

Site Contact

Elizabeth Gadroy, Dr

[email protected]

+33562877753

CHRU Tours Service de Dermatologie, Tours, France

Status

Recruiting

Address

CHRU Tours Service de Dermatologie

Tours, ,

Site Contact

Laurent MACHET, Pr

[email protected]

+33562877753

Dr Abdo-Morales, Tours, France

Status

Recruiting

Address

Dr Abdo-Morales

Tours, ,

Site Contact

Ivana Abdo-Morales, Dr

[email protected]

+33562877753

Barcelona, Spain

Status

Not yet recruiting

Address

Hospital de la Santa Creu i Sant Pau Dept. of Dermatology

Barcelona, ,

Site Contact

Lluis PUIG, Dr

[email protected]

+33562877753

Hospital Santa Caterina, Girona, Spain

Status

Recruiting

Address

Hospital Santa Caterina

Girona, ,

Site Contact

Margarida ROURA ROCH, Dr

[email protected]

+33562877753

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