Clinical trial NCT02098213: Evaluation of Spa Therapy in the Treatment of Plaque Psoriasis
Official title: Evaluation of Spa Therapy in the Treatment of Plaque Psoriasis, a Randomized, Controlled, Open Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plaque Psoriasis
Keywords: plaque psoriasis
DLQI
VQ Dermato
PASI
PASI change
phototherapy
balneotherapy
hydrotherapy
Euroquol EQ 5d scale
Visual analogic scale
SPA treatment Scale
PSS
Lead sponsor: Association Francaise pour la Recherche Thermale
Sponsor class: OTHER
Collaborators: name: University Hospital, Grenoble
name: Floralis
First posted: 2014-03-27
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Taking into account the hypothesis of a proportion of patients with a DLQI≤10 (absence of repercussion or low impact of psoriasis on quality of life) of 25% at 4 months 1/2 in the arm immediate spa treatment versus 10% in the usual care group (late spa treatment), 113 patients per group is required, with an alpha 5% risk and a power of 80 %. Given the risk of potential patients lost to follow-up estimates of 15%, we plan to include 130 patients per randomisation group, so 260 patients in total.

According to the protocol submitted to authorities, given the uncertainties of necessary hypothesis, a re-evaluation of the number of subjects required after the first 100 inclusions is planned. This reassessment will be carried out without intermediate analysis but in view of the results observed for the primary endpoint in mean and standard deviation (event driven).
Primary purpose: SUPPORTIVE_CARE

Brief summary: Assessment of quality of life after Spa therapy (4 ½ months follow-up) in the treatment of plaque psoriasis: Spa versus usual care in patients with plaque psoriasis.

Detailed description: Psoriasis is one of the most common skin diseases, affecting 2-3% of the general population; more than 1 million people in France.

This auto-immune erythematosquamous inflammatory dermatosis occurs on a particular genetic background and has a chronic course. Psoriasis has a history as an indication for dermatological spa treatment (water cures in the Dead Sea). As these treatments are a combination of balneotherapy and heliotherapy, many recent studies have attempted to assess the value and position the relative benefit of each therapeutic element. Over the last four decades various different phototherapy techniques have been widely used in the treatment of psoriasis. The thermal option for many psoriasis patients depends on personal choice, or their doctor's or dermatologist's recommendation. In 1994 only one third of the 16,875 spa treatments for dermatological conditions (about 5625 cures) were for psoriasis, suggesting that spa treatment is underused as a treatment for psoriasis. Nobody can challenge the therapeutic contribution of biotherapy in the treatment of anatomically destructive diseases such as rheumatoid arthritis and psoriatic arthritis, but the use of these treatments is not without risk and economic impact. There is thus a need for less intensive treatments that have little risk of serious side effects and are less expensive.

The use of spa therapy in psoriasis should be understood as complementary and not an alternative to all other treatments. The choice of treatment is guided by the patient's characteristics and pathology (concomitant diseases, extent of lesions, treatment history) and the specialty (adverse effects, cumulative dose). In psoriasis it may be necessary to use different lines of treatment because psoriasis is a lifetime disease. Side effects of systemic treatments such as biotherapy, cyclosporine, methotrexate, synthetic retinoids, and also phototherapy (PUVA and UVB) are cumulative over time. A course of spa treatment should allow a respite before resorting to other systemic therapy.

However, the spa dermatology still suffers from a lack of large-scale evaluation and especially an objective assessment using reliable methodologies that limit bias. This is the purpose of this study.

There are no randomized controlled multicenter clinical trials evaluating spa treatment for psoriasis, although an Italian non-randomized study included a few dozen patients and confirmed the clinical benefit of the treatment.

Eligibility criteria: Inclusion Criteria:

* Both sexes, over 18 years of age, patients with plaque psoriasis for more than one year diagnosed by a dermatologist
* Stable treatment in the last 6 months
* DLQI score \> 10
* patients volunteering for spa treatment within 6 weeks
* consenting to participate to the study with informed consent form signed after appropriate information
* Affiliation to the French social security system or equivalent

Exclusion Criteria:

* Pregnancy, parturient or breast feeding
* Psychiatric illness or social situation that would preclude study compliance
* Refusal of consent
* Refusal of spa treatment
* Contra-indication to spa treatment
* Phototherapy in the last 3 months
* Guttate, pustular or erythrodermic psoriasis Isolated nail psoriasis
* Spa therapy in the past year
* Person deprived of liberty or under legal guardianship

Primary outcomes:
measure: Dermatology Quality of Life Index (DQLI)
timeFrame: 4 ½ months after randomisation
Secondary outcomes:
measure: Specific Quality Of Life
timeFrame: 4 1/2, 6, 9 and 12 months after randomisation
measure: Global Quality Of Life
timeFrame: 4 1/2, 6, 9 and 12 months after randomisation
measure: Clinical benefit of the psoriasis
timeFrame: 4 1/2, 6, 9 and 12 months after randomisation
measure: pain and pruritus
timeFrame: 4 1/2, 6, 9 and 12 months after randomisation
measure: Treatment follow up
timeFrame: 4 1/2, 6, 9 and 12 months after randomisation
measure: patient's examination
timeFrame: 4 1/2, 6, 9 and 12 months after randomisation
measure: Safety evaluation
timeFrame: 4 1/2, 6, 9 and 12 months after randomisation
measure: Stress evaluation
timeFrame: 4 1/2, 6, 9 and 12 months after randomisatio
measure: Long term evaluation
timeFrame: 12 months
Other outcomes:
Locations:
city: Avene
country: France
facility: Station Thermale Avene
state: Languedoc-Rousillon
city: Molitg
country: France
facility: Thermes de Molitg les bains
state: Languedoc-Roussillon
city: La Roche Posay
country: France
facility: Thermes La Roche Posay
state: Poitou-Charentes
city: Le Fayet
country: France
facility: Les thermes de ST-GERVAIS
state: Rhône-Alpe
city: Uriage
country: France
facility: Etablissement thermal d'Uriage
state: Rhône-Alpe
Study officials:
affiliation: Bordeaux University Hospital - France
name: Marie MB BEYLOT-BARRY, Professor
role: PRINCIPAL_INVESTIGATOR
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