Clinical trial NCT06735911: Assessment of the Effect of a Dermatology-Oriented Spa Therapy on the Quality of Life of Patients With Psoriasis
Official title: Assessment at 4.5 Months of the Effect of a Dermatology-Oriented Spa Therapy on the Quality of Life of Patients With Psoriasis (BAREGES)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psoriasis
Keywords: psoriasis
spa therapy
Lead sponsor: Thermes de Bareges
Sponsor class: OTHER
Collaborators: name: Floralis
name: University Grenoble Alps
First posted: 2024-12-16
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: before / after study
Primary purpose: TREATMENT

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

Eligibility criteria: 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)

Primary outcomes:
measure: To evaluate the effect of a complete thermal treatment (moderate impact) for a dermatological indication on the quality of life of patients with psoriasis
timeFrame: 4.5 months
Secondary outcomes:
measure: 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
timeFrame: 4.5 months
measure: To evaluate dermatology-specific quality of life (quantitative DLQI score)
timeFrame: 4.5 and 9 months
measure: To evaluate overall quality of life using the EQ-5D-5L questionnaire.
timeFrame: 4.5 and 9 months
measure: To evaluate the clinical improvement of psoriasis in the short and medium term.
timeFrame: 4.5 and 9 months
measure: To evaluate pain and pruritus.
timeFrame: 4.5 and 9 months
measure: Physician/Patient perception : The physician's and patient's opinion will be requested to assess the perceived benefit of the treatment.
timeFrame: 4.5 and 9 months
measure: Medication consumption
timeFrame: 4.5 and 9 months
measure: Evolution of the general clinical criteria : Body Mass Index (BMI)
timeFrame: 4.5 and 9 months
measure: Evolution of the general clinical criteria : systolic blood pressure
timeFrame: 4.5 and 9 months
measure: Evolution of the general clinical criteria : diastolic blood pressure
timeFrame: 4.5 and 9 months
measure: Evolution of the general clinical criteria : heart rate
timeFrame: 4.5 and 9 months
measure: Evaluation of the use of care related or not to psoriasis at 4.5 and 9 months
timeFrame: 4.5 and 9 months
measure: Evaluation of compliance with the spa therapy
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupouy
city: Pierrefitte Nestalas
country: France
facility: Cabinet Luz Saint Sauveur
Study officials:
References:
citation: Lebwohl M, Ellis C, Gottlieb A, Koo J, Krueger G, Linden K, Shupack J, Weinstein G. Cyclosporine consensus conference: with emphasis on the treatment of psoriasis. J Am Acad Dermatol. 1998 Sep;39(3):464-75. doi: 10.1016/s0190-9622(98)70325-1.
citation: SOLOMON WM, NETHERTON EW, NELSON PA, ZEITER WJ. Treatment of psoriasis with Goeckerman technic. Arch Phys Med Rehabil. 1955 Feb;36(2):74-7. No abstract available.
citation: Kazandjieva J, Grozdev I, Darlenski R, Tsankov N. Climatotherapy of psoriasis. Clin Dermatol. 2008 Sep-Oct;26(5):477-85. doi: 10.1016/j.clindermatol.2008.05.001.