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

An Open-label Controlled Trial: Effectiveness of Saltwater-UVA, Tap Water-UVA, and Bath PUVA in the Treatment of Palmoplantar Psoriasis and Contact Dermatitis.

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis; Contact Dermatitis of Hand
• Intervention / Treatment: Other: salt water or tap water before UVA

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 Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Ankara University School of Medicine

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: bath puva; Patients received the standard protocol of bath PUVA with standard psoralen plus tap water in combination with a phototherapy regimen.
Experimental: salt water uva; Patients received saline solution (3% NaCl) in addition to UVA with standard phototherapy regimen.	Other: salt water or tap water before UVA; Instead of using standard bath PUVA, this study investigates the efficacy of tap water or salt water with UVA in the treatment of palmoplantar psoriasis.
Experimental: tap water uva; Patients received tap water in addition to UVA with standard phototherapy regimen.	Other: salt water or tap water before UVA; Instead of using standard bath PUVA, this study investigates the efficacy of tap water or salt water with UVA in the treatment of palmoplantar psoriasis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Severity Reduction	At least %50 reduction of the disease severity with the intervention groups at 36th week of the treatment	Disease Severity

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvevement in the Quality of Life	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	Qol

Collaborators and Investigators

• Sponsor: Ankara University
• Investigators: Study Director: Nihal Kundakcı, Prof, Ankara University Faculty of Medicine, Department of Dermatology and Venereology

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): May 10, 2017
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 25, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: phototherapy; bath puva; uva; psorolene; local uv a
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin Diseases, Eczematous; Psoriasis; Dermatitis; Dermatitis, Contact
• Other Study ID Numbers: BALNEOTERAPİ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: If needed, a masked individual participant data is and will be stored in the archives for a duration of 5 years

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