Back to resultsInvestigation With BiopH+Psoriasis Medical Bath in Subject With Mild to Moderate Plaque Psoriasis.
Primary Purpose
Plaque Psoriasis
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
BIOpH+ Psoriasis Medical Bath
Cetaphil Moisturizing Lotion
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Avdelningen för klinisk prövning
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BIOpH+ Psoriasis Medical Bath
Comparative device
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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. 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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05046899
Brief Title
Investigation With BiopH+Psoriasis Medical Bath in Subject With Mild to Moderate Plaque Psoriasis.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
June 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biocool AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intra-patient design.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIOpH+ Psoriasis Medical Bath
Arm Type
Experimental
Arm Description
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.
Arm Title
Comparative device
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
BIOpH+ Psoriasis Medical Bath
Intervention Description
20 min bath every day during 1 week and thereafter 20 min bath every second day for additional 7 weeks.
Intervention Type
Device
Intervention Name(s)
Cetaphil Moisturizing Lotion
Intervention Description
Cetaphil Moisturizing Lotion will be applied on the affected body area on the same days as the BIOpH+ Psoriasis Medical Bath is performed.
Primary Outcome Measure Information:
Title
Change in Psoriasis Area and Severity Index (PASI) score from Baseline compared to week 8.
Description
The PASI score is a validated, investigator instrument assessing the severity of psoriasis. The severity is combined with the percentage of affected area.
Time Frame
Baseline and week 8.
Secondary Outcome Measure Information:
Title
Dermatology Life Quality Index (DLQI)
Description
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.
Time Frame
Baseline and week 8.
Title
Psoriasis Area Severity Index (PASI)
Description
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. 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.
Time Frame
Week 2 and week 4
Title
Physician Global Assessment (PGA)
Description
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.
Time Frame
Baseline, week 2, 4, and 8
Title
Tolerability assessment
Description
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.
Time Frame
Week 2, 4 and week 8.
Title
Usability /satisfaction assessments
Description
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.
Time Frame
Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Lundvall, MD
Organizational Affiliation
Research Unit, University Hospital Örebro, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Avdelningen för klinisk prövning
City
Örebro
ZIP/Postal Code
70362
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
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Investigation With BiopH+Psoriasis Medical Bath in Subject With Mild to Moderate Plaque Psoriasis.
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