NCT05046899

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Biocool AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	BIOpH+ Psoriasis Medical Bath	20 min bath every day during 1 week and thereafter 20 min bath every second day for additional 7 weeks.
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.

Timeline

• Start date: 2021-09-14
• Primary completion: 2022-05-31
• Completion: 2022-06-13
• First posted: 2021-09-16
• Last updated: 2022-10-06

Locations

1 site across 1 country: Sweden