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

Launched by BIOCOOL AB · Sep 15, 2021

Keywords

ClinConnect Summary

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.

Gender

ALL

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