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

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

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

Study Overview

• Status: Recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Other: Spa therapy

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

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: FUSTIER NF Nans; Phone Number: 04 76 76 50 40; Email: nans.fustier@univ-grenoble-alpes.fr
• Study Contact Backup: Name: ROLLAND CR Carole; Phone Number: 04 76 76 50 40; Email: carole.rolland@univ-grenoble-alpes.fr

Study Locations

• France
  • Argenteuil, France, 95107
    • Recruiting
    • Centre Hospitalier Victor Dupouy
    • Contact: MAHE EM Emmanuel, Dr; Phone Number: 01 34 23 26 28; Email: emmanuel.mahe@ch-argenteuil.fr
    • Principal Investigator: MAHE EM Emmanuel, Dr
  • Pierrefitte Nestalas, France, 65120
    • Recruiting
    • Cabinet Luz Saint Sauveur
    • Contact: BENABI Bernard dr; Phone Number: 06 07 63 36 32; Email: bbenabi@icloud.com
    • Sub-Investigator: BENABI BB Bernard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: patient treated with a dermatology-oriented 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.	Other: 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.; Other Names: spa treatment; spa care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the effect of a complete thermal treatment (moderate impact) for a dermatological indication on the quality of life of patients with psoriasis	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.	4.5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of compliance with the spa therapy	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	3 weeks
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	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.	4.5 months
To evaluate dermatology-specific quality of life (quantitative DLQI score)	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.	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.	This evaluation will be conducted at the investigator's office 4.5 months and 9 months after inclusion using a 5-point Likert scale.	4.5 and 9 months
Medication consumption	Collection of medication consumption to evaluate the benefit of the spa therapy (comparison of consumption before and after treatment)	4.5 and 9 months
Evolution of the general clinical criteria : Body Mass Index (BMI)	Comparison of the Body Mass Index between enrolment, and 4.5 months and 9 months after enrolment	4.5 and 9 months
Evolution of the general clinical criteria : systolic blood pressure	Comparison of the systolic blood pressure between enrolment, and 4.5 months and 9 months after enrolment	4.5 and 9 months
Evolution of the general clinical criteria : diastolic blood pressure	Comparison of the diastolic blood pressure between enrolment, and 4.5 months and 9 months after enrolment	4.5 and 9 months
Evolution of the general clinical criteria : heart rate	Comparison of the heart rate between enrolment, and 4.5 months and 9 months after enrolment	4.5 and 9 months
Evaluation of the use of care related or not to psoriasis at 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)	4.5 and 9 months
To evaluate overall quality of life using the EQ-5D-5L questionnaire.	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.	4.5 and 9 months
To evaluate the clinical improvement of psoriasis in the short and medium term.	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.	4.5 and 9 months
To evaluate pain and pruritus.	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.	4.5 and 9 months

Collaborators and Investigators

• Sponsor: Thermes de Bareges
• Collaborators: University Grenoble Alps; Floralis

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: psoriasis; spa therapy
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID Numbers: 2024-A00700-47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No