An interventional study of salt water or tap water before UVA in Psoriasis and Contact Dermatitis of Hand, sponsored by Ankara University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by Ankara University · Not applicable, Interventional, and Treatment
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.
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 140 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Ankara University is the lead sponsor of 312 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients received the standard protocol of bath PUVA with standard psoralen plus tap water in combination with a phototherapy regimen.
Patients received saline solution (3% NaCl) in addition to UVA with standard phototherapy regimen.
Other: salt water or tap water before 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.
Disease Severity Reduction
At least %50 reduction of the disease severity with the intervention groups at 36th week of the treatment
Time frame: Disease Severity
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
Time frame: Qol
Plan to share: No — If needed, a masked individual participant data is and will be stored in the archives for a duration of 5 years
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ankara University