Chronic Pruritus Due to Plaque Psoriasis Clinical Trial
— PAPOfficial title:
An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy on Chronic Pruritus in Adults With Plaque Psoriasis
| NCT number | NCT03023254 |
| Other study ID # | PAP |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 6, 2017 |
| Est. completion date | July 20, 2020 |
| Verified date | April 2021 |
| Source | Pierre Fabre Dermo Cosmetique |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To assess the benefit of the Avène hydrotherapy in subjects with pruritic plaque psoriasis
| Status | Completed |
| Enrollment | 44 |
| Est. completion date | July 20, 2020 |
| Est. primary completion date | July 20, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | 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 | Dr Orsoni | Limoges | |
| France | Dr Gutmann Heller | Lingolsheim | |
| France | Dr Foucault | Lorient | |
| France | Dr Nicol | Marseille | |
| France | Dr Ruer-Mulard | Martigues | |
| France | Hôpital St Eloi Service de Dermatologie | Montpellier | |
| France | GHRMSA Hôpital Emile Muller Service de Dermatologie | Mulhouse | |
| France | CHU Nantes - Unité Dermato-Cancérologie 7° nord Hotel Dieu | Nantes | |
| France | Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) - Hôpital l'Archet 2 | Nice | |
| France | CHU Nice - Hôpital l'Archet 1 - Centre de recherche clinique | Nice | |
| France | Dr Fritsch | Obernai | |
| France | Dr Pfister | Paris | |
| France | CHU de Poitiers Pole régional de cancérologie Service de dermatologie | Poitiers | |
| France | Centre hospitalier Poissy St germain | Saint-Germain-en-Laye | |
| France | Dr Gadroy | Toulouse | |
| France | CHRU Tours Service de Dermatologie | Tours | |
| France | Dr Abdo-Morales | Tours | |
| Spain | Hospital de la Santa Creu i Sant Pau Dept. of Dermatology | Barcelona | |
| Spain | Hospital Santa Caterina | Girona |
| Lead Sponsor | Collaborator |
|---|---|
| Pierre Fabre Dermo Cosmetique |
France, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pruritus clinical criterion | Pruritus intensity assessed by the subject on the NRS from 0 to 10 | Day18 | |
| Secondary | Pruritus clinical criterion | Pruritus intensity assessed by the subject on the NRS from 0 to 10 | Day1 | |
| Secondary | Pruritus clinical criterion | Pruritus intensity assessed by the subject on the NRS from 0 to 10 | Day111 | |
| Secondary | Pruritus clinical criterion | Pruritus intensity assessed by the subject on the NRS from 0 to 10 | Day202 | |
| Secondary | Psoriasis clinical criterion | Psoriasis Area Severity Index assessed by the investigator on a scale ranged from 0 to 72 | Day1, Day18, Day111 and Day202 | |
| Secondary | Quality of life criterion | ItchyQoL questionnaire | Day1, Day18, Day111 and Day202 | |
| Secondary | Biological criterion (markers linked to neurogenic inflammation, epidermal differentiation, inflammation, antimicrobial peptides) | Psoriasis and pruritus biological markers | Day1, Day18, Day111 and Day202 | |
| Secondary | Hydrotherapy criterion | Hydrotherapy global cutaneous tolerance on 4-point scale (0 = No effective ; 1=Little effective ; 2=Effective and 3=Very effective) | Day18 |