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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05046899
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Biocool AB
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Martin Lundvall, MD
Principal Investigator Affiliation Research Unit, University Hospital Örebro, Sweden
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Sweden
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Additional Details

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.

Arms & Interventions

Arms

Experimental: BIOpH+ Psoriasis Medical Bath

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.

Active Comparator: Comparative device

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Avdelningen för klinisk prövning, Örebro, Sweden

Status

Recruiting

Address

Avdelningen för klinisk prövning

Örebro, , 70362

Site Contact

Lena Irvhage

lisa.welander@biocool.se

+ 46 (0)70 466 3123

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.