An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy

Pierre Fabre Dermo Cosmetique44 enrolled

Overview

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

* 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

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Chronic Pruritus Due to Plaque Psoriasis

Interventions

HydrotherapyOTHER

3-week Avène hydrotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (29)

CHU Nord Service de Dermatologie

Amiens, France

Outcomes

Primary Outcomes

Pruritus clinical criterion

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

Time frame: Day18

Secondary Outcomes

Pruritus clinical criterion

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

Time frame: Day1

Pruritus clinical criterion

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

Time frame: Day111

Pruritus clinical criterion

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

Time frame: Day202

Psoriasis clinical criterion

Psoriasis Area Severity Index assessed by the investigator on a scale ranged from 0 to 72

Time frame: Day1, Day18, Day111 and Day202

Quality of life criterion

ItchyQoL questionnaire

Time frame: Day1, Day18, Day111 and Day202

Biological criterion (markers linked to neurogenic inflammation, epidermal differentiation, inflammation, antimicrobial peptides)

Psoriasis and pruritus biological markers

Time frame: 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)

Time frame: Day18

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.