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The purpose of this investigation is to assess performance and safety of BIOpH+ Psoriasis Medical Bath in comparison to a comparative device.
After being informed about the investigation and the potential risks, all subjects giving written informed consent will undergo screening to determine eligibility for study entry. At week 0, subjects who meet the eligibility requirements will be randomised in open, intra-patient investigation, treated with BIOpH+ Psoriasis Medical Bath on one side, and comparative treatment on the other side for 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIOpH+ Psoriasis Medical Bath | Experimental | BIOpH+ Psoriasis Medical Bath is bath. Each bath will take 20 minutes and number of bath during the entire study period is approximately 35 baths. |
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| Comparative device | Active Comparator | Comparative device is Cetaphil Moisturizing Lotion. The lotion will be applied on the affected body area on the same days as the BIOpH+ Psoriasis Medical Bath is performed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIOpH+ Psoriasis Medical Bath | Device | 20 min bath every day during 1 week and thereafter 20 min bath every second day for additional 7 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Psoriasis Area and Severity Index (PASI) score from Baseline compared to week 8. | The PASI score is a validated, investigator instrument assessing the severity of psoriasis. The severity is combined with the percentage of affected area. | Baseline and week 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Dermatology Life Quality Index (DLQI) | A quality of life instrument and will evaluate how much the skin problems affects the study subject's daily life. It is a 10-question questionnaire. Each question contains four response categories: 0=not at all, 1=a little, 2=a lot, and 3=very much. A higher score means worse outcome. | Baseline and week 8. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Lundvall, MD | Research Unit, University Hospital Örebro, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avdelningen för klinisk prövning | Örebro | 70362 | Sweden |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 27, 2023 | |
| Reset | Feb 16, 2024 | |
| Release | Oct 17, 2024 | |
| Reset | Dec 6, 2024 | |
| Release | Jan 27, 2025 | |
| Reset | Feb 18, 2025 | |
| Release | Aug 15, 2025 | |
| Reset | Sep 4, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 27, 2023 | Feb 16, 2024 | |||
| Oct 17, 2024 |
Intra-patient design.
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| Cetaphil Moisturizing Lotion | Device | Cetaphil Moisturizing Lotion will be applied on the affected body area on the same days as the BIOpH+ Psoriasis Medical Bath is performed. |
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| Psoriasis Area Severity Index (PASI) | It combines the severity (erythema, induration and desquamation) and percentage of affected area. A high score means worse outcome. The body is divided into 4 sections:
For each section, the percent of area of skin involved is estimated and graded: 0. 0% of involved area
The sum of all 3 severity parameters is calculated for each body section, multiplied by the area score for that area, and multiplied for the weight of the body section, for a maximum score of 72. | Week 2 and week 4 |
| Physician Global Assessment (PGA) | The Physician Global Assessment, is a 5-point scoring system that will be used to assess the overall disease severity. This treatment response on each visit will be scored: 0 =cleared, 1=almost clear, 2=mild 3=moderate, and 4=severe. A higher scores mean worse outcome. | Baseline, week 2, 4, and 8 |
| Tolerability assessment | Tolerability assessment completed by the study subject about local tolerance regarding experience of pruritus and burning/stinging measured on a 5-point scale, or by questions to be answered with yes or no. | Week 2, 4 and week 8. |
| Usability /satisfaction assessments | A questionnaire to be answered by study subject about investigational device usability and satisfaction measured on a 5-point scale, or by questions to be answered with yes or no. | Week 8 |
| Dec 6, 2024 |
| Jan 27, 2025 | Feb 18, 2025 |
| Aug 15, 2025 | Sep 4, 2025 |