An Open-label Controlled Trial: Effectiveness of Balneotherapy in Palmoplantar Psoriasis and Contact Dermatitis.

Not Applicable

Completed

• Conditions: Contact Dermatitis of Hand; Psoriasis
• Interventions: Other: salt water or tap water before UVA

• Registration Number: NCT06458868
• Lead Sponsor: Ankara University

Brief Summary

Patients who had an indication for phototherapy were included in this study. The treatment was used as a monotherapy protocol.

The standard protocol for bathing PUVA involved applying 0.01% bath psoralen for 15 minutes, while the tap water group only received a tap water bath for 15 minutes and the salt water group received 3% salted (NaCl) water before UVA treatment.

Main tools to assess the efficacy is disease activity scores and quaity of Life scores.

Detailed Description

Patients who met the criteria for phototherapy were included in this study. The treatment was used as a standalone protocol, with only moisturizer permitted. In order to participate, patients needed to have completed their last systemic treatment at least 2 months prior to the study, and their last topical treatment at least 4 weeks prior.

Patients were randomized using a computer program and assessed at the beginning of therapy, as well as after 12, 24, and 36 sessions. The standard bath-PUVA protocol involved applying 0.01% bath psoralen for 15 minutes, while the tap water group only received a tap water bath for 15 minutes, and the salt water group received a 3% salt water bath before UVA exposure.

All patients were educated about their condition and current treatment options. Patients who participated in this study either had contraindications to other therapies or had experienced side effects previously.

The initial UVA dosage was 0.25 J/cm2, gradually increasing to a maximum of 5 J/cm2. During each evaluation, patients were assessed using various scales and tools to measure the severity of their psoriasis and their quality of life, as well as photographs.

Following a pilot study involving 5 patients in each group, a two score reduction in the disease activity score revealed that G power analysis determined that a total of at least 13 patients was needed to achieve 80% power. Ethical approval was obtained before commencing the study.

Study Timeline

• Study Start: 2014-06-01
• Primary Completion: 2017-05-10
• Study Completion: 2023-10-01
• Study First Submitted: 2024-05-29
• Study First Submitted QC: 2024-06-10
• Study First Posted: 2024-06-14
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-25
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Individuals aged between 18 and 65
• Clinical diagnosis of Palmoplantar Psoriasis or Contact Dermatitis

Exclusion Criteria

• Individuals under 18 or over 65
• Pregnancy or breastfeeding
• History of malignancy
• Diagnosis of photodermatosis
• Prescription or use of photoallergenic or phototoxic drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tap water uva	salt water or tap water before UVA	Patients received tap water in addition to UVA with standard phototherapy regimen.
salt water uva	salt water or tap water before UVA	Patients received saline solution (3% NaCl) in addition to UVA with standard phototherapy regimen.

Primary Outcome Measures

Name	Time	Method
Disease Severity Reduction	Disease Severity	At least %50 reduction of the disease severity with the intervention groups at 36th week of the treatment

Secondary Outcome Measures

Name	Time	Method
Improvevement in the Quality of Life	Qol	statistically significant improvement in the quality of life of the patients compared to the beginning of the study at the 36the week of the treatment

Trial Locations

Locations (1)

Ankara University School of Medicine; 🇹🇷 Ankara, Turkey