Evaluation of Spa Therapy in the Treatment of Plaque Psoriasis
- Conditions
- Plaque Psoriasis
- Interventions
- Other: Immediate spa treatmentOther: Late Spa treatment
- Registration Number
- NCT02098213
- Lead Sponsor
- Association Francaise pour la Recherche Thermale
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immediate Spa treatment Immediate spa treatment Three week course of spa treatment soon after randomization Late Spa treatment Late Spa treatment Three week course of spa treatment soon after 4,5 months visit
- Primary Outcome Measures
Name Time Method Dermatology Quality of Life Index (DQLI) 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.
- Secondary Outcome Measures
Name Time Method Specific Quality Of Life 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 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 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 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 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 monthspatient's examination 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 pressureSafety evaluation 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 4 1/2, 6, 9 and 12 months after randomisatio self administered questionnaire (PSS: Assessment of stress) at inclusion in the study only
Long term evaluation 12 months Evaluation of the maintenance of benefits at 12 months (stability of the long term effect) on the primary outcome and secondary outcomes.
Trial Locations
- Locations (5)
Station Thermale Avene
🇫🇷Avene, Languedoc-Rousillon, France
Thermes de Molitg les bains
🇫🇷Molitg, Languedoc-Roussillon, France
Les thermes de ST-GERVAIS
🇫🇷Le Fayet, Rhône-Alpe, France
Thermes La Roche Posay
🇫🇷La Roche Posay, Poitou-Charentes, France
Etablissement thermal d'Uriage
🇫🇷Uriage, Rhône-Alpe, France