NCT06735911

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
25mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Apr 2025May 2028

First Submitted

Initial submission to the registry

December 11, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

April 28, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

1.2 years

First QC Date

December 11, 2024

Last Update Submit

May 12, 2025

Conditions

Keywords

psoriasisspa therapy

Outcome Measures

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

    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 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

    4.5 months

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

    4.5 and 9 months

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

    4.5 and 9 months

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

    4.5 and 9 months

  • To evaluate pain and pruritus.

    4.5 and 9 months

  • +8 more secondary outcomes

Study Arms (1)

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.

Other: Spa therapy

Interventions

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

Also known as: spa treatment, spa care
Experimental: patient treated with a dermatology-oriented spa therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Victor Dupouy

Argenteuil, 95107, France

RECRUITING

Cabinet Luz Saint Sauveur

Pierrefitte-Nestalas, 65120, France

RECRUITING

Related Publications (3)

  • 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: 9738783BACKGROUND
  • 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: 13229486BACKGROUND
  • 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: 18755366BACKGROUND

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: before / after study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2024

First Posted

December 16, 2024

Study Start

April 28, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

May 1, 2028

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations