PsoriasisBAREGESNCT06735911
Assessment of the Effect of a Dermatology-Oriented Spa Therapy on the Quality of Life of Patients With Psoriasis
A study testing Spa therapy in people with Psoriasis, run by Thermes de Bareges at 2 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Spa therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesFrance
- Study dates
- 28 Apr 2025to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Centre Hospitalier Victor Dupouy
Argenteuil, 95107
MAHE EM Emmanuel, Dr, 01 34 23 26 28, emmanuel.mahe@ch-argenteuil.fr
MAHE EM Emmanuel, Dr
- Recruiting
Cabinet Luz Saint Sauveur
Pierrefitte-Nestalas, 65120
BENABI Bernard dr, 06 07 63 36 32, bbenabi@icloud.com
BENABI BB Bernard
About this study
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)
Evaluation of the effect of a dermatology-oriented spa therapy at 4.5 months on the quality of life of patients suffering from psoriasis
Read the 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
- Conditions
- Psoriasis
- Being tested
- Spa therapy
- Keywords
- psoriasis, spa therapy
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spa therapyOther
Also called spa treatment, spa care
Thermal treatments among the following: Filiform shower, simple bath, aerated bath, general shower, compresses, nebulization inhalation, multiple local mud applications, and drinking cure.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: patient treated with a dermatology-oriented spa therapy | Experimental | Thermal treatments among the following: Filiform shower, simple bath, aerated bath, general shower, compresses, nebulization inhalation, multiple local mud applications, and drinking cure. Receives: Other: Spa therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4.5 months
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 4.5 and 9 months
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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start28 Apr 2025
- Primary completionJul 2026 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- before / after study
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thermes de Bareges
- Sponsor type
- University, hospital or other
- Collaborators
- Floralis, University Grenoble Alps
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735911
- Sponsor's protocol ID
- 2024-A00700-47
- Acronym
- BAREGES
- Status last verified
- May 2025
- First submitted
- 11 Dec 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 9738783SOLOMON 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.
PubMed 13229486Kazandjieva 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.
PubMed 18755366
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06735911
- Acronym / sponsor ID
- BAREGES / 2024-A00700-47
- Conditions
- Psoriasis
- Keywords
- psoriasis, spa therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Thermes de BaregesUniversity, hospital or other
- Collaborators
- Floralis, University Grenoble Alps
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- before / after study
| Arm | Type | Receives |
|---|---|---|
| Experimental: patient treated with a dermatology-oriented spa therapy | Experimental | Other: Spa therapyThermal treatments among the following: Filiform shower, simple bath, aerated bath, general shower, compresses, nebulization inhalation, multiple local mud applications, and drinking cure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spa therapyAlso: spa treatment, spa careThermal treatments among the following: Filiform shower, simple bath, aerated bath, general shower, compresses, nebulization inhalation, multiple local mud applications, and drinking cure. | Other | Experimental: patient treated with a dermatology-oriented spa therapy |
Primary outcome
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.
13 secondary outcomes
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
To evaluate dermatology-specific quality of life (quantitative DLQI score)
Time frame: 4.5 and 9 months
To evaluate overall quality of life using the EQ-5D-5L questionnaire.
Time frame: 4.5 and 9 months
To evaluate the clinical improvement of psoriasis in the short and medium term.
Time frame: 4.5 and 9 months
To evaluate pain and pruritus.
Time frame: 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.
Time frame: 4.5 and 9 months
Medication consumption
Time frame: 4.5 and 9 months
Evolution of the general clinical criteria : Body Mass Index (BMI)
Time frame: 4.5 and 9 months
Evolution of the general clinical criteria : systolic blood pressure
Time frame: 4.5 and 9 months
Evolution of the general clinical criteria : diastolic blood pressure
Time frame: 4.5 and 9 months
Evolution of the general clinical criteria : heart rate
Time frame: 4.5 and 9 months
Evaluation of the use of care related or not to psoriasis at 4.5 and 9 months
Time frame: 4.5 and 9 months
Evaluation of compliance with the spa therapy
Time frame: 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Background: PubMed 9738783Lebwohl 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.
- Background: PubMed 13229486SOLOMON 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.
- Background: PubMed 18755366Kazandjieva 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spa therapy in people with Psoriasis, run by Thermes de Bareges at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact FUSTIER NF Nans (04 76 76 50 40, nans.fustier@univ-grenoble-alpes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 4.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06735911, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.