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

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ClinicalTrials.gov Identifier: NCT03023254
Recruitment Status : Unknown
Verified January 2017 by Pierre Fabre Dermo Cosmetique.
Recruitment status was:  Not yet recruiting
First Posted : January 18, 2017
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Dermo Cosmetique

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

Condition or disease Intervention/treatment Phase
Chronic Pruritus Due to Plaque Psoriasis Other: Hydrotherapy Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy on Chronic Pruritus in Adults With Plaque Psoriasis
Study Start Date : March 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching Psoriasis

Arm Intervention/treatment
hydrotherapy group
Subjects included in the "hydrotherapy group" will undergo a 3-weeks Avène hydrotherapy in addition to their usual psoriasis and/or pruritus management (treatments and/or skin care products).
Other: Hydrotherapy
3-weeks Avène hydrotherapy

No Intervention: Control group
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).



Primary Outcome Measures :
  1. Pruritus clinical criterion [ Time Frame: Day18 ]
    Pruritus intensity assessed by the subject on the NRS from 0 to 10


Secondary Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Criteria related to the matching:

Subject matched with an included subject of the hydrotherapy group in terms of:

  • Gender: subject must be of the same gender as his/her matched hydrotherapy group subject
  • Age: subject must be in the same age group as his/her matched hydrotherapy group subject (at the time of inclusion visit):
  • either between 18 and 50 years old included
  • or over 51 years old included
  • Investigator: subject must be enrolled at the same peripheral investigational site as his/her matched hydrotherapy group subject
  • Inclusion period: subject must be included within the 28 days following the inclusion of his/her matched hydrotherapy group subject
  • Pruritus intensity: subject must have the same pruritus intensity level as his/her matched hydrotherapy group subject (at the time of inclusion visit):
  • either moderate pruritus (NRS score, evaluated on average over the 3 days, between 4 and 6 included on a scale ranged from 0 to 10)
  • or severe to very severe pruritus (NRS score, evaluated on average over the 3 days, between 7 and 10 included on a scale ranged from 0 to 10)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023254


Contacts
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Contact: Fabienne CARBALLIDO +33562870171 fabienne.carballido@pierre-fabre.com

Sponsors and Collaborators
Pierre Fabre Dermo Cosmetique

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Responsible Party: Pierre Fabre Dermo Cosmetique
ClinicalTrials.gov Identifier: NCT03023254     History of Changes
Other Study ID Numbers: HDcli_2016_AVEN_158_PAP
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Psoriasis
Pruritus
Skin Diseases, Papulosquamous
Skin Diseases
Skin Manifestations
Signs and Symptoms