Skip to main content
OpenTrials
Completed

NCT Number: NCT05046899

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Avdelningen för klinisk prövning

Örebro, 70362, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Baseline and 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.

Secondary outcomes

  1. Dermatology Life Quality Index (DLQI)

    Time frame: Baseline and week 8.

    A quality of life instrument and will evaluate how much the skin problems affects the study subject's daily life. It is a 10-question questionnaire. Each question contains four response categories: 0=not at all, 1=a little, 2=a lot, and 3=very much. A higher score means worse outcome.

  2. Psoriasis Area Severity Index (PASI)

    Time frame: Week 2 and week 4

    It combines the severity (erythema, induration and desquamation) and percentage of affected area. A high score means worse outcome.

    The body is divided into 4 sections:

    • Head, weight = 0.1
    • Arms, weight = 0.2
    • Trunk, weight = 0.3
    • Legs, weight = 0.4

    For each section, the percent of area of skin involved is estimated and graded:

    • 0% of involved area
    • <10% of involved area
    • 10-29% of involved area
    • 30-49% of involved area
    • 50-69% of involved area
    • 70-89% of involved area
    • 90-100% of involved area Within each area, the severity is estimated for 3 clinical signs: erythema (redness), induration (thickness) and desquamation (scaling). Severity is measured on a scale from 0-4, from none to maximum.

    The sum of all 3 severity parameters is calculated for each body section, multiplied by the area score for that area, and multiplied for the weight of the body section, for a maximum score of 72.

  3. Physician Global Assessment (PGA)

    Time frame: Baseline, week 2, 4, and 8

    The Physician Global Assessment, is a 5-point scoring system that will be used to assess the overall disease severity. This treatment response on each visit will be scored: 0 =cleared, 1=almost clear, 2=mild 3=moderate, and 4=severe. A higher scores mean worse outcome.

  4. Tolerability assessment

    Time frame: Week 2, 4 and week 8.

    Tolerability assessment completed by the study subject about local tolerance regarding experience of pruritus and burning/stinging measured on a 5-point scale, or by questions to be answered with yes or no.

  5. Usability /satisfaction assessments

    Time frame: Week 8

    A questionnaire to be answered by study subject about investigational device usability and satisfaction measured on a 5-point scale, or by questions to be answered with yes or no.

Sponsors and collaborators

Lead sponsor

Biocool AB

Industry

Registry information

Official study title

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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2021
Registry last updated
Oct 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.