Evaluation of Spa Therapy in the Treatment of Plaque Psoriasis

Study Overview
=================
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.

Official Title
-----------------
Evaluation of Spa Therapy in the Treatment of Plaque Psoriasis, a Randomized, Controlled, Open Multicenter Study

Conditions
-----------------
Plaque Psoriasis

Intervention / Treatment
-----------------
* Other: Immediate spa treatment
* Other: Late Spa treatment


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate Spa treatment<br>Three week course of spa treatment soon after randomization | Other: Immediate spa treatment<br>* soon after randomization: Spa treatment of 3 weeks. Spa treatment : that best adapted to the concerned pathology and common to all participating of spa resorts (walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massaging shower etc)<br>* Other names: Spa treatment soon after randomisation;|
| Sham Comparator: Late Spa treatment<br>Three week course of spa treatment soon after 4,5 months visit | Other: Late Spa treatment<br>* soon after 4,5 months visit: Spa treatment of 3 weeks. Spa treatment : that best adapted to the concerned pathology and common to all of spa resorts (walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massaging shower etc)<br>* Other names: Spa treatment after 4,5 months visit in the study;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermatology Quality of Life Index (DQLI) | proportion of patients with a score ≤ 10 at 4½ months in each arm of the study, spa treatment versus usual care. | 4 ½ months after randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific Quality Of Life | proportion of patients in each arm of the study (spa treatment versus usual care) for the following specific dermatology questionnaires : DLQI score ≤ 10 at 6, 9 and 12 months and VQ Dermato score > 35 at 4 1/2, 6, 9 and 12 months | 4 1/2, 6, 9 and 12 months after randomisation | 
| Global Quality Of Life | EuroQOL 5D questionnaire at 4 1/2, 6, 9 and 12 months | 4 1/2, 6, 9 and 12 months after randomisation | 
| Clinical benefit of the psoriasis | proportion of patients with a PASI (Psoriasis Area and Severity Index) 50 and PASI 75 at 4½, 6, 9 and 12 months in each arm of the study, spa treatment versus usual care. | 4 1/2, 6, 9 and 12 months after randomisation | 
| pain and pruritus | Self-administered questionnaire with Visual Analogue Scale for pain and for pruritus at 4 1/2, 6, 9, 12 months | 4 1/2, 6, 9 and 12 months after randomisation | 
| Treatment follow up | Assessment of topical treatments within 12 months (number of tubes used per month) Number of phototherapy sessions Use of conventional systemic therapies (acitretin, methotrexate, cyclosporine) (number of weeks of treatment and dosage) Number of weeks of treatment by biotherapy Reduction in the use of the health care system (Number of hospitalizations and specialized consultations in connection with psoriasis or not) within 12 months Reports on the use of complementary and alternative medicines within12 months | 4 1/2, 6, 9 and 12 months after randomisation | 
| patient's examination | Impact of the spa treatment on overall metabolism indicators in the year Will be collected at 4 1/2, 6, 9 and 12 months in the two groups: height an weight (BMI calculation) Waist measurement Blood pressure | 4 1/2, 6, 9 and 12 months after randomisation | 
| Safety evaluation | Evaluation of all adverse events attributable to treatment, or not, according to the usual criteria of pharmacovigilance in clinical trials | 4 1/2, 6, 9 and 12 months after randomisation | 
| Stress evaluation | self administered questionnaire (PSS: Assessment of stress) at inclusion in the study only | 4 1/2, 6, 9 and 12 months after randomisatio | 
| Long term evaluation | Evaluation of the maintenance of benefits at 12 months (stability of the long term effect) on the primary outcome and secondary outcomes. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
plaque psoriasis, DLQI, VQ Dermato, PASI, PASI change, phototherapy, balneotherapy, hydrotherapy, Euroquol EQ 5d scale, Visual analogic scale, SPA treatment Scale, PSS