Clinical trial NCT05046899: 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
Overall status: COMPLETED
Phase: NA
Conditions: Plaque Psoriasis
Lead sponsor: Biocool AB
Sponsor class: INDUSTRY
First posted: 2021-09-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intra-patient design.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Psoriasis Area and Severity Index (PASI) score from Baseline compared to week 8.
timeFrame: Baseline and week 8.
Secondary outcomes:
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Baseline and week 8.
measure: Psoriasis Area Severity Index (PASI)
timeFrame: Week 2 and week 4
measure: Physician Global Assessment (PGA)
timeFrame: Baseline, week 2, 4, and 8
measure: Tolerability assessment
timeFrame: Week 2, 4 and week 8.
measure: Usability /satisfaction assessments
timeFrame: Week 8
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Avdelningen för klinisk prövning
Study officials:
affiliation: Research Unit, University Hospital Örebro, Sweden
name: Martin Lundvall, MD
role: PRINCIPAL_INVESTIGATOR
References: