Plaque Psoriasis
Conditions
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.
Interventions
DEVICEBIOpH+ Psoriasis Medical Bath
20 min bath every day during 1 week and thereafter 20 min bath every second day for additional 7 weeks.
DEVICECetaphil Moisturizing Lotion
Cetaphil Moisturizing Lotion will be applied on the affected body area on the same days as the BIOpH+ Psoriasis Medical Bath is performed.
Sponsors
Biocool AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Intra-patient design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Psoriasis Area and Severity Index (PASI) score from Baseline compared to week 8. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dermatology Life Quality Index (DLQI) | Baseline and week 8. | 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) | Week 2 and week 4 | 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: 1. Head, weight = 0.1 2. Arms, weight = 0.2 3. Trunk, weight = 0.3 4. Legs, weight = 0.4 For each section, the percent of area of skin involved is estimated and graded: 0\. 0% of involved area 1. \<10% of involved area 2. 10-29% of involved area 3. 30-49% of involved area 4. 50-69% of involved area 5. 70-89% of involved area 6. 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) | Baseline, week 2, 4, and 8 | 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 | Week 2, 4 and week 8. | 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 | Week 8 | 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. |
Countries
Sweden
Outcome results
None listed