Clinical trial NCT06458868: An Open-label Controlled Trial: Effectiveness of Balneotherapy in Palmoplantar Psoriasis and Contact Dermatitis.
Official title: An Open-label Controlled Trial: Effectiveness of Saltwater-UVA, Tap Water-UVA, and Bath PUVA in the Treatment of Palmoplantar Psoriasis and Contact Dermatitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Contact Dermatitis of Hand
Keywords: bath puva
uva
psorolene
phototherapy
local uv a
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective single center open label three parallel group, adaptive randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease Severity Reduction
timeFrame: Disease Severity
Secondary outcomes:
measure: Improvevement in the Quality of Life
timeFrame: Qol
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University School of Medicine
Study officials:
affiliation: Ankara University Faculty of Medicine, Department of Dermatology and Venereology
name: Nihal Kundakcı, Prof
role: STUDY_DIRECTOR
References: