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Completed

NCT Number: NCT03023254

An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy

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

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Key information

Conditions

Chronic Pruritus Due to Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nord Service de Dermatologie, Amiens, France

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About this study

  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrotherapy

Other

3-week Avène hydrotherapy

Primary outcomes

  1. Pruritus clinical criterion

    Time frame: Day18

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

Secondary outcomes

  1. Pruritus clinical criterion

    Time frame: Day1

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

  2. Pruritus clinical criterion

    Time frame: Day111

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

  3. Pruritus clinical criterion

    Time frame: Day202

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

  4. Psoriasis clinical criterion

    Time frame: Day1, Day18, Day111 and Day202

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

  5. Quality of life criterion

    Time frame: Day1, Day18, Day111 and Day202

    ItchyQoL questionnaire

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

    Time frame: Day1, Day18, Day111 and Day202

    Psoriasis and pruritus biological markers

  7. Hydrotherapy criterion

    Time frame: Day18

    Hydrotherapy global cutaneous tolerance on 4-point scale (0 = No effective ; 1=Little effective ; 2=Effective and 3=Very effective)

Sponsors and collaborators

Lead sponsor

Pierre Fabre Dermo Cosmetique

Industry

Registry information

Official study title

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

Acronym: PAP

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 18, 2017
Registry last updated
Apr 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.