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NCT Number: NCT06735911

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

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

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Victor Dupouy, Argenteuil, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Spa therapy

Other

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

Primary outcomes

  1. To evaluate the effect of a complete thermal treatment (moderate impact) for a dermatological indication on the quality of life of patients with psoriasis

    Time frame: 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 outcomes

  1. 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

    Time frame: 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.

  2. To evaluate dermatology-specific quality of life (quantitative DLQI score)

    Time frame: 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.

  3. To evaluate overall quality of life using the EQ-5D-5L questionnaire.

    Time frame: 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.

  4. To evaluate the clinical improvement of psoriasis in the short and medium term.

    Time frame: 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.

  5. To evaluate pain and pruritus.

    Time frame: 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.

  6. Physician/Patient perception : The physician's and patient's opinion will be requested to assess the perceived benefit of the treatment.

    Time frame: 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.

  7. Medication consumption

    Time frame: 4.5 and 9 months

    Collection of medication consumption to evaluate the benefit of the spa therapy (comparison of consumption before and after treatment)

  8. Evolution of the general clinical criteria : Body Mass Index (BMI)

    Time frame: 4.5 and 9 months

    Comparison of the Body Mass Index between enrolment, and 4.5 months and 9 months after enrolment

  9. Evolution of the general clinical criteria : systolic blood pressure

    Time frame: 4.5 and 9 months

    Comparison of the systolic blood pressure between enrolment, and 4.5 months and 9 months after enrolment

  10. Evolution of the general clinical criteria : diastolic blood pressure

    Time frame: 4.5 and 9 months

    Comparison of the diastolic blood pressure between enrolment, and 4.5 months and 9 months after enrolment

  11. Evolution of the general clinical criteria : heart rate

    Time frame: 4.5 and 9 months

    Comparison of the heart rate between enrolment, and 4.5 months and 9 months after enrolment

  12. Evaluation of the use of care related or not to psoriasis at 4.5 and 9 months

    Time frame: 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)

  13. Evaluation of compliance with the spa therapy

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

FUSTIER NF Nans

CONTACT

[email protected]

04 76 76 50 40

ROLLAND CR Carole

CONTACT

[email protected]

04 76 76 50 40

Sponsors and collaborators

Lead sponsor

Thermes de Bareges

Other

Collaborators

  • Floralis
  • University Grenoble Alps

Registry information

Official study 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)

Acronym: BAREGES

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Dec 16, 2024
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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