Assessment of the Effect of a Dermatology-Oriented Spa Therapy on the Quality of Life of Patients With Psoriasis

Официальное название

Assessment at 4.5 Months of the Effect of a Dermatology-Oriented Spa Therapy on the Quality of Life of Patients With Psoriasis (BAREGES)

Обзор

Evaluation of the effect of a dermatology-oriented spa therapy at 4.5 months on the quality of life of patients suffering from psoriasis

Подробное описание

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

Вмешательства

• Другое Spa therapy
  Thermal treatments among the following: Filiform shower, simple bath, aerated bath, general shower, compresses, nebulization inhalation, multiple local mud applications, and drinking cure.

Первичные конечные точки

• To evaluate the effect of a complete thermal treatment (moderate impact) for a dermatological indication on the quality of life of patients with psoriasis [Срок оценки: 4.5 months]

Вторичные конечные точки (12)

• 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 [Срок оценки: 4.5 months]
• To evaluate dermatology-specific quality of life (quantitative DLQI score) [Срок оценки: 4.5 and 9 months]
• To evaluate overall quality of life using the EQ-5D-5L questionnaire. [Срок оценки: 4.5 and 9 months]
• To evaluate the clinical improvement of psoriasis in the short and medium term. [Срок оценки: 4.5 and 9 months]
• To evaluate pain and pruritus. [Срок оценки: 4.5 and 9 months]
• Physician/Patient perception : The physician's and patient's opinion will be requested to assess the perceived benefit of the treatment. [Срок оценки: 4.5 and 9 months]
• Medication consumption [Срок оценки: 4.5 and 9 months]
• Evolution of the general clinical criteria : Body Mass Index (BMI) [Срок оценки: 4.5 and 9 months]
• Evolution of the general clinical criteria : systolic blood pressure [Срок оценки: 4.5 and 9 months]
• Evolution of the general clinical criteria : diastolic blood pressure [Срок оценки: 4.5 and 9 months]
• Evolution of the general clinical criteria : heart rate [Срок оценки: 4.5 and 9 months]
• Evaluation of the use of care related or not to psoriasis at 4.5 and 9 months [Срок оценки: 4.5 and 9 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 2 центра

• Centre Hospitalier Victor Dupouy — Argenteuil
• Cabinet Luz Saint Sauveur — Pierrefitte-Nestalas

Публикации

• 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. PMID 9738783
• 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. PMID 13229486
• 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. PMID 18755366

Идентификаторы

NCT: NCT06735911 · 2024-A00700-47

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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