An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy (PAP)

Pierre Fabre

Status: Completed

Conditions: Chronic Pruritus Due to Plaque Psoriasis

Treatments: Other: Hydrotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03023254

PAP

Details and patient eligibility

About

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

Full 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)

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

hydrotherapy group

Other group

Description:

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).

Treatment:

Other: Hydrotherapy

Control group

No Intervention group

Description:

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).