A 16-week Randomized Evaluation of the Impact of Mind.Px Application on Response to Biologic Treatment in Patients Suffering From Plaque Psoriasis Through Clinical Utility and Health Outcomes.

Study Purpose

This protocol describes randomized, multicenter, blinded (subjects), 16-week, controlled study in parallel balanced groups of psoriasis (Ps) patients to evaluate the impact of Mind.Px on response to biologic treatments. Patients enrolled in this study will be required to have diagnosis of Ps and a total score ≥10 on the PASI and the identified study-lesion must have a PGA severity ≥3 on a 5-point scale of 0 to 4. Patients suffering from Ps will be enrolled in the study and randomized on a 1:1 basis to treatment as usual (TAU) or to treatment decision utilizing Mind.Px (MND). Both groups will have a dermal patch applied and analyzed. The TAU group will not be provided the results of the dermal patch until the end of the last study visit. The MND group will be provided the results of the dermal patch upon the completion of the analysis.

Recruitment Criteria

Accepts Healthy Volunteers

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

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.

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

Inclusion Criteria:

1. Subject must have the ability to understand and sign written informed consent. 2. Subject must be an adult male or female adult who is ≥ 18 years of age at the time of screening. 3. Subject must be diagnosed with plaque psoriasis by either a dermatologist or a rheumatologist, with the affected area of ≥ 2 centimeters in diameter (study-lesion). 4. Subjects must be treated with an anti-IL-17, anti-IL-23, or an anti TNF-α biologic. 5. Subject must abstain from the use of any treatment to the identified study-lesion after screening until the baseline visit (this includes biologic treatments until after the dermal patch sample has been collected). 6. Subjects must abstain from the use of steroid or any topical treatment to the identified study lesion from screening till the last study visit. 7. Subjects must have a baseline PASI ≥10 and the identified study-lesion must have a PGA severity ≥3 on a 5-point scale of 0 to 4. 8. Agree to abide by the study protocol and its restrictions and be able to complete all aspects of the study, including all visits and tests.

Exclusion Criteria:

1. Subject is unable or unwilling to give written informed consent and/or to comply with study procedures. 2. Subject has had new usage of topical psoriasis treatments within 2 weeks prior to screening study visit (these concomitant immunomodulatory treatments such as corticosteroid/calcineurin inhibitors). 3. Subjects currently treated with Hydroxychloroquine (Plaquenil). 4. Subjects has had usage of anti TNF-α, IL-12/23, IL-17, IL-23, JAK inhibitor, or T-cell activation inhibitor, therapy within 2 weeks prior to baseline, unless otherwise approved by Sponsor. 5. More than 2 prior treatments with a biologic therapy. 6. Subjects with a BMI ≥40 and a diagnosis of Class III (Severe) Obesity (or solely a diagnosis of Class III (Severe) Obesity). 7. Any change in biologic medication (including change in dosage) between screening and randomization. 8. No phototherapy or other oral systemic therapy (acitretin, ciclosporin, methotrexate, apremilast, fumarate, oral JAK inhibitor, or T-cell activation inhibitor) at least 2 weeks before baseline and throughout study.

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.


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.

Lead Sponsor

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

Mindera Health
Principal Investigator

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

Principal Investigator Affiliation N/A
Agency Class

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

Overall Status Not yet recruiting

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

Plaque Psoriasis
Arms & Interventions


Experimental: MND

Subject's physician in this group will be using the Mind.Px report as a treatment reference for prescribing the subject's biologic.

No Intervention: TAU

Treatment as usual. This group will have the biologic prescribed with results given to the physician at the end of the subject's participation and will not be used as a reference for the subject's treatment.


Diagnostic Test: - Mind.Px Report

Use of Mind.Px report as a reference for potential better matching of biologics to patients.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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