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

Biocool

Status: Completed

Conditions: Plaque Psoriasis

Treatments: Device: Cetaphil Moisturizing Lotion; Device: BIOpH+ Psoriasis Medical Bath

Study type: Interventional

Funder types: Industry

Identifiers

NCT05046899

BioC002

Details and patient eligibility

About

The purpose of this investigation is to assess performance and safety of BIOpH+ Psoriasis Medical Bath in comparison to a comparative device.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

BIOpH+ Psoriasis Medical Bath

Experimental group

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.

Treatment:

Device: BIOpH+ Psoriasis Medical Bath

Comparative device

Active Comparator group

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.

Treatment:

Device: Cetaphil Moisturizing Lotion