Psoriasis
Conditions
Keywords
psoriasis, spa therapy
Brief summary
Evaluation of the effect of a dermatology-oriented spa therapy at 4.5 months on the quality of life of patients suffering from psoriasis
Detailed description
BAREGES is a: prospective, before/after, cohort follow-up study with repeated measurements monocentric study with the dispensation of a 3-week dermatolgy-oriented spa therapy in Barèges
Interventions
OTHERSpa therapy
Thermal treatments among the following: Filiform shower, simple bath, aerated bath, general shower, compresses, nebulization inhalation, multiple local mud applications, and drinking cure.
Sponsors
Floralis
University Grenoble Alps
Thermes de Bareges
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
before / after study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years Patient with psoriasis Stable treatment in the last 6 months. DLQI \> 10 Patient presenting an indication for thermal treatment focused on dermatology (possible dual orientation). Patient affiliated to the social security system or such a system Available for an 18-day spa treatment and a 9-month follow-up For women of childbearing age: effective contraception Patient information and informed consent signature
Exclusion criteria
Contraindication to thermal treatment (e.g., ongoing chemotherapy/radiotherapy, uncontrolled progressive neoplasia, progressive heart disease, etc., according to the investigator's assessment) Predictable intolerance to thermal treatments (intolerance to heat, baths, etc.) Patient who has already undergone a dermatology-oriented spa treatment within the current thermal season Subject already included in an interventional clinical research protocol Persons referred to in articles L1121-5 to L1121-8 of the Code de la Santé Publique (pregnant women, women in labour and parturient and nursing mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure or not being able to verbally communicate their agreement, minor)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effect of a complete thermal treatment (moderate impact) for a dermatological indication on the quality of life of patients with psoriasis | 4.5 months | Percentage of patients with a score ≤ 10 (moderate impact) on the Dermatology Life Quality Index (DLQI) questionnaire at 4.5 months.The DLQI score is between 0 and 30 where a high score indicates a significant impairment of quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate dermatology-specific quality of life (quantitative DLQI score) | 4.5 and 9 months | Comparison of the mean scores of the dermatology-specific quality of life questionnaire (DLQI) at inclusion (pre-thermal treatment), at 4.5 months (post-thermal treatment), and at 9 months after inclusion.The DLQI score is between 0 and 30 where a high score indicates a significant impairment of quality of life. |
| To evaluate overall quality of life using the EQ-5D-5L questionnaire. | 4.5 and 9 months | Change in overall quality of life (EQ-5D-5L questionnaire) between inclusion, 4.5 months, and 9 months after inclusion. The EQ5D-5L essentially consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). There are five dimensions assessed in the descriptive system: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. A higher score means better outcome. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. Score from 0 to 100. A higher score means better outcome. |
| To evaluate the clinical improvement of psoriasis in the short and medium term. | 4.5 and 9 months | The PASI (Psoriasis Area and Severity Index) is a scale used to assess the clinical severity of psoriasis. The PASI will be measured at inclusion, 4.5 months, and 9 months. The minimum PASI score is 0, indicating no lesions. The maximum PASI score is 72, representing maximum involvement of all body areas with the highest severity. |
| To evaluate pain and pruritus. | 4.5 and 9 months | A self-questionnaire (Visual Analog Scale) will be presented to the patients to measure pain and pruritus associated with skin lesions at inclusion, 4.5 months, and 9 months. These two results will be analyzed quantitatively. The minimum score is 0, indicating no pain or pruritus, while the maximum score is 10, representing the worst imaginable pain or intolerable pruritus. |
| Physician/Patient perception : The physician's and patient's opinion will be requested to assess the perceived benefit of the treatment. | 4.5 and 9 months | This evaluation will be conducted at the investigator's office 4.5 months and 9 months after inclusion using a 5-point Likert scale. |
| Medication consumption | 4.5 and 9 months | Collection of medication consumption to evaluate the benefit of the spa therapy (comparison of consumption before and after treatment) |
| To evaluate the effect of a complete thermal treatment (low impact) for a dermatological indication on the quality of life of patients with psoriasis at 4.5 months, taking into account all the care provided | 4.5 months | Percentage of patients with a score ≤ 5 (low impact) on the Dermatology Life Quality Index (DLQI) questionnaire at 4.5 months. The DLQI score is between 0 and 30 where a high score indicates a significant impairment of quality of life. |
| Evolution of the general clinical criteria : systolic blood pressure | 4.5 and 9 months | Comparison of the systolic blood pressure between enrolment, and 4.5 months and 9 months after enrolment |
| Evolution of the general clinical criteria : diastolic blood pressure | 4.5 and 9 months | Comparison of the diastolic blood pressure between enrolment, and 4.5 months and 9 months after enrolment |
| Evolution of the general clinical criteria : heart rate | 4.5 and 9 months | Comparison of the heart rate between enrolment, and 4.5 months and 9 months after enrolment |
| Evaluation of the use of care related or not to psoriasis at 4.5 and 9 months | 4.5 and 9 months | Collection of medical events related or not to psoriasis (number of SAE, number of hospitalizations, number of medical and paramedical procedures) |
| Evaluation of compliance with the spa therapy | 3 weeks | Comparison of the thermal treatments received by the patient during the spa therapy with the thermal treatments prescribed by the thermal doctor at the start of the spa therapy, collected in the spa treatment booklet |
| Evolution of the general clinical criteria : Body Mass Index (BMI) | 4.5 and 9 months | Comparison of the Body Mass Index between enrolment, and 4.5 months and 9 months after enrolment |
Countries
France
Contacts
Primary ContactFUSTIER NF Nans
Backup ContactROLLAND CR Carole
Outcome results
None listed