Evaluation of Spa Therapy in the Treatment of Plaque Psoriasis
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|ClinicalTrials.gov Identifier: NCT02098213|
Recruitment Status : Active, not recruiting
First Posted : March 27, 2014
Last Update Posted : January 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Plaque Psoriasis||Other: Immediate spa treatment Other: Late Spa treatment||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|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).
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Spa Therapy in the Treatment of Plaque Psoriasis, a Randomized, Controlled, Open Multicenter Study|
|Actual Study Start Date :||January 2015|
|Estimated Primary Completion Date :||May 15, 2019|
|Estimated Study Completion Date :||December 2019|
Active Comparator: Immediate Spa treatment
Three week course of spa treatment soon after randomization
Other: Immediate spa treatment
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)
Other Name: Spa treatment soon after randomisation
Sham Comparator: Late Spa treatment
Three week course of spa treatment soon after 4,5 months visit
Other: Late Spa treatment
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)
Other Name: Spa treatment after 4,5 months visit in the study
- Dermatology Quality of Life Index (DQLI) [ Time Frame: 4 ½ months after randomisation ]proportion of patients with a score ≤ 10 at 4½ months in each arm of the study, spa treatment versus usual care.
- Specific Quality Of Life [ Time Frame: 4 1/2, 6, 9 and 12 months after randomisation ]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
- Global Quality Of Life [ Time Frame: 4 1/2, 6, 9 and 12 months after randomisation ]EuroQOL 5D questionnaire at 4 1/2, 6, 9 and 12 months
- Clinical benefit of the psoriasis [ Time Frame: 4 1/2, 6, 9 and 12 months after randomisation ]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.
- pain and pruritus [ Time Frame: 4 1/2, 6, 9 and 12 months after randomisation ]Self-administered questionnaire with Visual Analogue Scale for pain and for pruritus at 4 1/2, 6, 9, 12 months
- Treatment follow up [ Time Frame: 4 1/2, 6, 9 and 12 months after randomisation ]
- 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
- patient's examination [ Time Frame: 4 1/2, 6, 9 and 12 months after randomisation ]
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
- Safety evaluation [ Time Frame: 4 1/2, 6, 9 and 12 months after randomisation ]Evaluation of all adverse events attributable to treatment, or not, according to the usual criteria of pharmacovigilance in clinical trials
- Stress evaluation [ Time Frame: 4 1/2, 6, 9 and 12 months after randomisatio ]self administered questionnaire (PSS: Assessment of stress) at inclusion in the study only
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): NCT02098213
|Station Thermale Avene|
|Avene, Languedoc-Rousillon, France, 34260|
|Thermes de Molitg les bains|
|Molitg, Languedoc-Roussillon, France, 66500|
|Thermes La Roche Posay|
|La Roche Posay, Poitou-Charentes, France, 86270|
|Les thermes de ST-GERVAIS|
|Le Fayet, Rhône-Alpe, France, 74190|
|Etablissement thermal d'Uriage|
|Uriage, Rhône-Alpe, France, 38410|
|Principal Investigator:||Marie MB BEYLOT-BARRY, Professor||Bordeaux University Hospital - France|