An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy
- Conditions
- Chronic Pruritus Due to Plaque Psoriasis
- Registration Number
- NCT03023254
- Lead Sponsor
- Pierre Fabre Dermo Cosmetique
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pruritus clinical criterion Day18 Pruritus intensity assessed by the subject on the NRS from 0 to 10
- Secondary Outcome Measures
Name Time Method Pruritus clinical criterion Day202 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
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)
Quality of life criterion Day1, Day18, Day111 and Day202 ItchyQoL questionnaire
Trial Locations
- Locations (29)
CHU Nord Service de Dermatologie
🇫🇷Amiens, France
CHU Angers Service de Dermatologie
🇫🇷Angers, France
Dr Martins-Hericher
🇫🇷Angers, France
CH de Boulogne sur Mer Hôpital DUCHENE - service de dermatologie
🇫🇷Boulogne-sur-Mer, France
CHU Morvan service de dermatologie
🇫🇷Brest, France
Dr Durbise
🇫🇷Cahors, France
Dr Parant
🇫🇷Clisson, France
Centre Hospitalier de Dunkerque - Service de Dermatologie
🇫🇷Dunkerque, France
Dr Abbadie
🇫🇷Langon, France
Dr Durieu
🇫🇷Lavaur, France
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