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

NCT05046899 | Completed

• 1 other identifier: BioC002
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Change in Psoriasis Area and Severity Index (PASI) score from Baseline compared to week 8.

  The PASI score is a validated, investigator instrument assessing the severity of psoriasis. The severity is combined with the percentage of affected area.

  Baseline and week 8.

Secondary Outcomes (5)

• Dermatology Life Quality Index (DLQI)

  Baseline and week 8.

• Psoriasis Area Severity Index (PASI)

  Week 2 and week 4

• Physician Global Assessment (PGA)

  Baseline, week 2, 4, and 8

• Tolerability assessment

  Week 2, 4 and week 8.

• Usability /satisfaction assessments

  Week 8

Study Arms (2)

BIOpH+ Psoriasis Medical Bath

EXPERIMENTAL

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.

Device: BIOpH+ Psoriasis Medical Bath

Comparative device

ACTIVE COMPARATOR

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.

Device: Cetaphil Moisturizing Lotion

Interventions

BIOpH+ Psoriasis Medical Bath DEVICE

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

BIOpH+ Psoriasis Medical Bath

Cetaphil Moisturizing Lotion DEVICE

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

Comparative device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biocool AB: lead

Study Sites (1)

Avdelningen för klinisk prövning

Örebro, 70362, Sweden

Location

Study Officials

• Martin Lundvall, MD

  Research Unit, University Hospital Örebro, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intra-patient design.

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 16, 2021
• Study Start: September 14, 2021
• Primary Completion: May 31, 2022
• Study Completion: June 13, 2022
• Last Updated: October 6, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)