Chronic Pruritus Due to Plaque Psoriasis
Conditions
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)
Interventions
OTHERHydrotherapy
3-week Avène hydrotherapy
Sponsors
Pierre Fabre Dermo Cosmetique
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pruritus clinical criterion | Day18 | Pruritus intensity assessed by the subject on the NRS from 0 to 10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biological criterion (markers linked to neurogenic inflammation, epidermal differentiation, inflammation, antimicrobial peptides) | Day1, Day18, Day111 and Day202 | Psoriasis and pruritus biological markers |
| Hydrotherapy criterion | Day18 | Hydrotherapy global cutaneous tolerance on 4-point scale (0 = No effective ; 1=Little effective ; 2=Effective and 3=Very effective) |
| Pruritus clinical criterion | Day1 | Pruritus intensity assessed by the subject on the NRS from 0 to 10 |
| Psoriasis clinical criterion | Day1, Day18, Day111 and Day202 | Psoriasis Area Severity Index assessed by the investigator on a scale ranged from 0 to 72 |
| Quality of life criterion | Day1, Day18, Day111 and Day202 | ItchyQoL questionnaire |
Countries
France, Spain
Outcome results
None listed