An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy

Study Overview
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Brief Summary
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To assess the benefit of the Avène hydrotherapy in subjects with pruritic plaque psoriasis

Detailed Description
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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)

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

Conditions
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Chronic Pruritus Due to Plaque Psoriasis

Intervention / Treatment
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* Other: Hydrotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: hydrotherapy group<br>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<br>* 3-week Avène hydrotherapy<br>|
| No Intervention: Control group<br>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?
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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 |