Investigation With BiopH+Psoriasis Medical Bath in Subject With Mild to Moderate Plaque Psoriasis.

NCT ID: NCT05046899

Last Updated: 2022-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-14
• Study Completion Date: 2022-06-13

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.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BIOpH+ Psoriasis Medical Bath

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.

Group Type: EXPERIMENTAL

BIOpH+ Psoriasis Medical Bath

Intervention Type: DEVICE

20 min bath every day during 1 week and thereafter 20 min bath every second day for additional 7 weeks.

Comparative device

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.

Group Type: ACTIVE_COMPARATOR

Cetaphil Moisturizing Lotion

Intervention Type: DEVICE

Cetaphil Moisturizing Lotion will be applied on the affected body area on the same days as the BIOpH+ Psoriasis Medical Bath is performed.

Interventions

BIOpH+ Psoriasis Medical Bath

20 min bath every day during 1 week and thereafter 20 min bath every second day for additional 7 weeks.

Intervention Type: DEVICE

Cetaphil 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biocool AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Lundvall, MD

Role: PRINCIPAL_INVESTIGATOR

Research Unit, University Hospital Örebro, Sweden

Locations

Avdelningen för klinisk prövning

Örebro, , Sweden

Countries

Sweden

Other Identifiers

BioC002

Identifier Type: -

Identifier Source: org_study_id