Plaque PsoriasisNCT05046899
Investigation With BiopH+Psoriasis Medical Bath in Subject With Mild to Moderate Plaque Psoriasis.
A study testing BIOpH+ Psoriasis Medical Bath and Cetaphil Moisturizing Lotion in people with Plaque Psoriasis, run by Biocool AB at 1 site in Sweden.
Trial summary
The purpose of this investigation is to assess performance and safety of BIOpH+ Psoriasis Medical Bath in comparison to a comparative device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- BIOpH+ Psoriasis Medical Bath and Cetaphil Moisturizing Lotion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- 14 Sep 2021to 13 Jun 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary agreed to participation and has duly signed Informed Consent Form
- Males and females ≥ 18 years of age
- In the Investigator's opinion, the patient is not likely to become pregnant during study participation (e.g. in a same-sex relationship, not sexually active, sterile, not of child-bearing age, uses contraception, etc.)
- Subject diagnosed with stable mild-moderate plaque psoriasis, defined by PASI ≤ 9
- Intra-individual difference between left and right hemi-body PASI scores not > 1.0
- Patients with symmetrical psoriasis
Who cannot join
- Presence of other forms of psoriasis other than psoriasis vulgaris (palmoplantar psoriasis, inverse psoriasis, other forms of hyperkeratosis)
- Use of systemic/biological treatment for psoriasis
- Known hypersensitivity or allergy to study products
- Any serious medical condition that could interfere with the evaluation of study results
- Poor compliance in other investigational study, as assessed by investigator
- Pregnant, breastfeeding, or planning to become pregnant during study
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- Patients with alcohol -or drug abuse
- Any other conditions as judged by the investigator may make the follow-up or investigation inappropriate
- Anyone unsuitable to participate as subject according to the Declaration of Helsinki
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Intra-patient Investigation to Assess the Clinical Performance and Safety of BIOpH+ Psoriasis Medical Bath for 8 Weeks of Treatment in Subjects With Mild to Moderate Plaque Psoriasis of Affected Body Area.
The purpose of this investigation is to assess performance and safety of BIOpH+ Psoriasis Medical Bath in comparison to a comparative device.
Read the detailed description
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.
- Conditions
- Plaque Psoriasis
- Being tested
- BIOpH+ Psoriasis Medical Bath, Cetaphil Moisturizing Lotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOpH+ Psoriasis Medical BathDevice
20 min bath every day during 1 week and thereafter 20 min bath every second day for additional 7 weeks.
Cetaphil Moisturizing LotionDevice
Cetaphil Moisturizing Lotion will be applied on the affected body area on the same days as the BIOpH+ Psoriasis Medical Bath is performed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: BIOpH+ Psoriasis Medical Bath |
| 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. Receives: Device: Cetaphil Moisturizing Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 8.
Secondary outcomes (5)
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.
Measured: Baseline and week 8.
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:
- Head, weight = 0.1
- Arms, weight = 0.2
- Trunk, weight = 0.3
- Legs, weight = 0.4
For each section, the percent of area of skin involved is estimated and graded:
- 0% of involved area
- <10% of involved area
- 10-29% of involved area
- 30-49% of involved area
- 50-69% of involved area
- 70-89% of involved area
- 90-100% of involved area Within each area, the severity is estimated for 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity is measured on a scale from 0-4, from none to maximum.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start14 Sep 2021
- Primary completion31 May 2022
- Study completion13 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- 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
- Intra-patient design.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocool AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Lundvall, MD, Principal investigator, Research Unit, University Hospital Örebro, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046899
- Sponsor's protocol ID
- BioC002
- Status last verified
- Oct 2022
- First submitted
- 7 Sep 2021
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Intra-patient Investigation to Assess the Clinical Performance and Safety of BIOpH+ Psoriasis Medical Bath for 8 Weeks of Treatment in Subjects With Mild to Moderate Plaque Psoriasis of Affected Body Area.
- ClinicalTrials.gov ID
- NCT05046899
- Acronym / sponsor ID
- BioC002
- Conditions
- Plaque Psoriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Biocool ABIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 16 Sep 2021 (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.
The purpose of this investigation is to assess performance and safety of BIOpH+ Psoriasis Medical Bath in comparison to a comparative device.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intra-patient design.
| Arm | Type | Receives |
|---|---|---|
| BIOpH+ Psoriasis Medical Bath | Experimental | Device: BIOpH+ Psoriasis Medical BathBIOpH+ Psoriasis Medical Bath is bath. Each bath will take 20 minutes and number of bath during the entire study period is approximately 35 baths. |
| Comparative device | Active comparator | Device: Cetaphil Moisturizing LotionComparative 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntary agreed to participation and has duly signed Informed Consent Form
- Males and females ≥ 18 years of age
- In the Investigator's opinion, the patient is not likely to become pregnant during study participation (e.g. in a same-sex relationship, not sexually active, sterile, not of child-bearing age, uses contraception, etc.)
- Subject diagnosed with stable mild-moderate plaque psoriasis, defined by PASI ≤ 9
- Intra-individual difference between left and right hemi-body PASI scores not > 1.0
Key exclusion criteria (9 listed)
- Presence of other forms of psoriasis other than psoriasis vulgaris (palmoplantar psoriasis, inverse psoriasis, other forms of hyperkeratosis)
- Use of systemic/biological treatment for psoriasis
- Known hypersensitivity or allergy to study products
- Any serious medical condition that could interfere with the evaluation of study results
- Poor compliance in other investigational study, as assessed by investigator
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 |
|---|---|---|
| BIOpH+ Psoriasis Medical Bath20 min bath every day during 1 week and thereafter 20 min bath every second day for additional 7 weeks. | Device | BIOpH+ Psoriasis Medical Bath |
| Cetaphil Moisturizing LotionCetaphil Moisturizing Lotion will be applied on the affected body area on the same days as the BIOpH+ Psoriasis Medical Bath is performed. | Device | Comparative device |
Primary outcome
Change in Psoriasis Area and Severity Index (PASI) score from Baseline compared to week 8.
Time frame: Baseline and 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.
5 secondary outcomes
Dermatology Life Quality Index (DLQI)
Time frame: Baseline and week 8.
Psoriasis Area Severity Index (PASI)
Time frame: Week 2 and week 4
Physician Global Assessment (PGA)
Time frame: Baseline, week 2, 4, and 8
Tolerability assessment
Time frame: Week 2, 4 and week 8.
Usability /satisfaction assessments
Time frame: Week 8
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 6 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Martin Lundvall, MD principal investigator
Research Unit, University Hospital Örebro, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIOpH+ Psoriasis Medical Bath and Cetaphil Moisturizing Lotion in people with Plaque Psoriasis, run by Biocool AB at 1 site in Sweden.
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 6 inclusion and 9 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 6 Oct 2022. 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 Sweden. 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?
Change in Psoriasis Area and Severity Index (PASI) score from Baseline compared to week 8. (time frame: Baseline and week 8.). 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 6 Oct 2022.