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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06458868
Enrollment
140
Registered
2024-06-14
Start date
2014-06-01
Completion date
2023-10-01
Last updated
2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contact Dermatitis of Hand, Psoriasis

Keywords

bath puva, uva, psorolene, phototherapy, local uv a

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.

Interventions

OTHERsalt 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.

Sponsors

Ankara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Endpoint assessors blinded

Intervention model description

Prospective single center open label three parallel group, adaptive randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Disease Severity ReductionDisease SeverityAt least %50 reduction of the disease severity with the intervention groups at 36th week of the treatment

Secondary

MeasureTime frameDescription
Improvevement in the Quality of LifeQolstatistically significant improvement in the quality of life of the patients compared to the beginning of the study at the 36the week of the treatment

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026