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An Exploratory Study to Assess the Efficacy of the Avène Hydrotherapy

Study Purpose

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

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

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An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


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Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03023254

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Pierre Fabre Dermo Cosmetique

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
N/A
Principal Investigator Affiliation N/A

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Not yet recruiting
Countries

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Chronic Pruritus Due to Plaque Psoriasis
Additional Details

- 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)

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Fabienne CARBALLIDO

+33562870171

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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