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

Psoriasis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06458868
• Other study ID #: SifaOkulu
• Status: Completed
• Phase: N/A
• Start date: June 1, 2014
• Est. completion date: October 1, 2023

Study information

• Verified date: June 2024
• Source: Sifa Okulu - Independent Research Center of Dermatology and Venereology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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, which aimed to demonstrate that there would be no difference between the treatment procedures, a G power analysis determined that a total of 54 patients was needed to achieve 80% power. Ethical approval was obtained before commencing the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 1, 2023
• Est. primary completion date: May 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Contact
• Psoriasis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Sifa Okulu Independent Center of Dermatological Research	Altinordu	Ordu

Sponsors (1)

Lead Sponsor	Collaborator
Sifa Okulu - Independent Research Center of Dermatology and Venereology

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Severity Reduction	At least %50 reduction of the disease severity with the intervention groups at 36th week of the treatment	Disease Severity
Secondary	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