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

Ankara University

Status: Completed

Conditions: Psoriasis; Contact Dermatitis of Hand

Treatments: Other: salt water or tap water before UVA

Study type: Interventional

Funder types: Other

Identifiers

NCT06458868

BALNEOTERAPİ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

140 participants in 3 patient groups

bath puva

No Intervention group

Description:

Patients received the standard protocol of bath PUVA with standard psoralen plus tap water in combination with a phototherapy regimen.

salt water uva

Experimental group

Description:

Patients received saline solution (3% NaCl) in addition to UVA with standard phototherapy regimen.

Treatment:

Other: salt water or tap water before UVA

tap water uva

Experimental group

Description:

Patients received tap water in addition to UVA with standard phototherapy regimen.

Treatment:

Other: salt water or tap water before UVA