Chronic Pruritus Due to Plaque PsoriasisPAPNCT03023254

An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy

A study testing Hydrotherapy in people with Chronic Pruritus Due to Plaque Psoriasis, run by Pierre Fabre Dermo Cosmetique at 29 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To assess the benefit of the Avène hydrotherapy in subjects with pruritic plaque psoriasis Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Pruritus Due to Plaque Psoriasis
What is being tested?: Hydrotherapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 29 sitesin 2 countries
Study dates: 6 Mar 2017to 20 Jul 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

29 sites in 2 countries.

Country

City, postcode or hospital

29 sites in 2 countries

France27 sites

CHU Nord Service de Dermatologie
Amiens
CHU Angers Service de Dermatologie
Angers
Dr Martins-Hericher
Angers
CH de Boulogne sur Mer Hôpital DUCHENE - service de dermatologie
Boulogne-sur-Mer
CHU Morvan service de dermatologie
Brest
Dr Durbise
Cahors
Dr Parant
Clisson
Centre Hospitalier de Dunkerque - Service de Dermatologie
Dunkirk
Dr Abbadie
Langon
Dr Durieu
Lavaur
Dr Orsoni
Limoges
Dr Gutmann Heller
Lingolsheim
Dr Foucault
Lorient
Dr Nicol
Marseille
Dr Ruer-Mulard
Martigues
Hôpital St Eloi Service de Dermatologie
Montpellier
GHRMSA Hôpital Emile Muller Service de Dermatologie
Mulhouse
CHU Nantes - Unité Dermato-Cancérologie 7° nord Hotel Dieu
Nantes
Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) - Hôpital l'Archet 2
Nice
CHU Nice - Hôpital l'Archet 1 - Centre de recherche clinique
Nice
Dr Fritsch
Obernai
Dr Pfister
Paris
CHU de Poitiers Pole régional de cancérologie Service de dermatologie
Poitiers
Centre hospitalier Poissy St germain
Saint-Germain-en-Laye
Dr Gadroy
Toulouse
CHRU Tours Service de Dermatologie
Tours
Dr Abdo-Morales
Tours

Other trials in France

Spain2 sites

Hospital de la Santa Creu i Sant Pau Dept. of Dermatology
Barcelona
Hospital Santa Caterina
Girona

Other trials in Spain

About this study

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

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

Read the 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)

Conditions: Chronic Pruritus Due to Plaque Psoriasis
Being tested: Hydrotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HydrotherapyOther
3-week Avène hydrotherapy

Study groups in NCT03023254
Study group	Role	What they receive
hydrotherapy group	Other	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). Receives: Other: Hydrotherapy
Control group	No intervention	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 being measured

The primary outcome is the main question the study is designed to answer.

Pruritus clinical criterion
Pruritus intensity assessed by the subject on the NRS from 0 to 10
Measured: Day18

Secondary outcomes (7)

Pruritus clinical criterion
Pruritus intensity assessed by the subject on the NRS from 0 to 10
Measured: Day1
Pruritus clinical criterion
Pruritus intensity assessed by the subject on the NRS from 0 to 10
Measured: Day111
Pruritus clinical criterion
Pruritus intensity assessed by the subject on the NRS from 0 to 10
Measured: Day202
Psoriasis clinical criterion
Psoriasis Area Severity Index assessed by the investigator on a scale ranged from 0 to 72
Measured: Day1, Day18, Day111 and Day202
Quality of life criterion
ItchyQoL questionnaire
Measured: Day1, Day18, Day111 and Day202
Biological criterion (markers linked to neurogenic inflammation, epidermal differentiation, inflammation, antimicrobial peptides)
Psoriasis and pruritus biological markers
Measured: 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)
Measured: Day18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Mar 201720 Jul 2020

First posted18 Jan 2017 (estimated)
Study start6 Mar 2017
Primary completion20 Jul 2020
Study completion20 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Pruritus Due to Plaque PsoriasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03023254
Sponsor's protocol ID: PAP
Acronym: PAP
Status last verified: Apr 2021
First submitted: 25 Oct 2016
Last updated: 2 Apr 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Thouvenin MD, Bacquey A, Babin M, Lestienne F, Lauze C, Gravier E, Placintescu D, Ortiz-Brugues A, Stander S. Efficacy of Avene Hydrotherapy on Chronic Pruritus in Patients with Plaque Psoriasis. Dermatol Ther (Heidelb). 2023 Dec;13(12):3137-3151. doi: 10.1007/s13555-023-01047-2. Epub 2023 Oct 14.
PubMed 37837493

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy on Chronic Pruritus in Adults With Plaque Psoriasis
ClinicalTrials.gov ID: NCT03023254
Acronym / sponsor ID: PAP / PAP
Conditions: Chronic Pruritus Due to Plaque Psoriasis
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
Study start: 6 Mar 2017 (actual)
Primary completion: 20 Jul 2020 (actual)
Study completion: 20 Jul 2020 (actual)
First posted: 18 Jan 2017 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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)

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
hydrotherapy group	Other	Other: HydrotherapySubjects 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).
Control group	No intervention	–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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hydrotherapy3-week Avène hydrotherapy	Other	hydrotherapy group

Primary outcome

Pruritus clinical criterion
Time frame: Day18
Pruritus intensity assessed by the subject on the NRS from 0 to 10

7 secondary outcomes

Pruritus clinical criterion
Time frame: Day1
Pruritus clinical criterion
Time frame: Day111
Pruritus clinical criterion
Time frame: Day202
Psoriasis clinical criterion
Time frame: Day1, Day18, Day111 and Day202
Quality of life criterion
Time frame: Day1, Day18, Day111 and Day202
Biological criterion (markers linked to neurogenic inflammation, epidermal differentiation, inflammation, antimicrobial peptides)
Time frame: Day1, Day18, Day111 and Day202
Hydrotherapy criterion
Time frame: Day18

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
Derived from this study: PubMed 37837493Thouvenin MD, Bacquey A, Babin M, Lestienne F, Lauze C, Gravier E, Placintescu D, Ortiz-Brugues A, Stander S. Efficacy of Avene Hydrotherapy on Chronic Pruritus in Patients with Plaque Psoriasis. Dermatol Ther (Heidelb). 2023 Dec;13(12):3137-3151. doi: 10.1007/s13555-023-01047-2. Epub 2023 Oct 14.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Diana PLACINTESCU, MD principal investigator

Les Thermes d'Avène

29 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Hydrotherapy in people with Chronic Pruritus Due to Plaque Psoriasis, run by Pierre Fabre Dermo Cosmetique at 29 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pruritus clinical criterion (time frame: Day18). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03023254, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021.