PsoriasisNCT06458868
An Open-label Controlled Trial: Effectiveness of Balneotherapy in Palmoplantar Psoriasis and Contact Dermatitis.
A study testing salt water or tap water before UVA in people with Psoriasis and Contact Dermatitis of Hand, run by Ankara University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis, Contact Dermatitis of Hand
- What is being tested?
- salt water or tap water before UVA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2014to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged between 18 and 65
- Clinical diagnosis of Palmoplantar Psoriasis or Contact Dermatitis
Who cannot join
- Individuals under 18 or over 65
- Pregnancy or breastfeeding
- History of malignancy
- Diagnosis of photodermatosis
- Prescription or use of photoallergenic or phototoxic drugs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University School of Medicine
Ankara, 06100
About this study
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.
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.
Read the 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.
- Conditions
- Psoriasis, Contact Dermatitis of Hand
- Being tested
- salt water or tap water before UVA
- Keywords
- bath puva, uva, psorolene, phototherapy, local uv a
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salt water or tap water before UVAOther
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.
| Study group | Role | What they receive |
|---|---|---|
| bath puva | No intervention | Patients received the standard protocol of bath PUVA with standard psoralen plus tap water in combination with a phototherapy regimen. |
| salt water uva | Experimental | Patients received saline solution (3% NaCl) in addition to UVA with standard phototherapy regimen. Receives: Other: salt water or tap water before UVA |
| tap water uva | Experimental | Patients received tap water in addition to UVA with standard phototherapy regimen. Receives: Other: salt water or tap water before UVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Severity Reduction
At least %50 reduction of the disease severity with the intervention groups at 36th week of the treatment
Measured: Disease Severity
Secondary outcomes (1)
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
Measured: Qol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Jun 2014
- Primary completion10 May 2017
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective single center open label three parallel group, adaptive randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilayda Karakok Kısla, Ankara University
- Investigators
- Nihal Kundakcı, Prof, Study director, Ankara University Faculty of Medicine, Department of Dermatology and Venereology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458868
- Sponsor's protocol ID
- BALNEOTERAPİ
- Status last verified
- Dec 2024
- First submitted
- 29 May 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If needed, a masked individual participant data is and will be stored in the archives for a duration of 5 years
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06458868
- Acronym / sponsor ID
- BALNEOTERAPİ
- Conditions
- Psoriasis, Contact Dermatitis of Hand
- Keywords
- bath puva, uva, psorolene, phototherapy, local uv a
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 10 May 2017 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective single center open label three parallel group, adaptive randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| bath puva | No intervention | –Patients received the standard protocol of bath PUVA with standard psoralen plus tap water in combination with a phototherapy regimen. |
| salt water uva | Experimental | Other: salt water or tap water before UVAPatients received saline solution (3% NaCl) in addition to UVA with standard phototherapy regimen. |
| tap water uva | Experimental | Other: salt water or tap water before UVAPatients received tap water in addition to UVA with standard phototherapy regimen. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals aged between 18 and 65
- Clinical diagnosis of Palmoplantar Psoriasis or Contact Dermatitis
Key exclusion criteria (5 listed)
- Individuals under 18 or over 65
- Pregnancy or breastfeeding
- History of malignancy
- Diagnosis of photodermatosis
- Prescription or use of photoallergenic or phototoxic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salt water or tap water before UVAInstead of using standard bath PUVA, this study investigates the efficacy of tap water or salt water with UVA in the treatment of palmoplantar psoriasis. | Other | salt water uva, tap water uva |
Primary outcome
Disease Severity Reduction
Time frame: Disease Severity
At least %50 reduction of the disease severity with the intervention groups at 36th week of the treatment
1 secondary outcome
Improvevement in the Quality of Life
Time frame: Qol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No. If needed, a masked individual participant data is and will be stored in the archives for a duration of 5 years
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nihal Kundakcı, Prof study director
Ankara University Faculty of Medicine, Department of Dermatology and Venereology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing salt water or tap water before UVA in people with Psoriasis and Contact Dermatitis of Hand, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Severity Reduction (time frame: Disease Severity). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.