Evaluation of Tolerability, Efficacy and Adherence to Treatment With Wynzora Cream

Study Purpose

The primary objective is to assess with the PPQ questionnaire the patient preference for Wynzora compared with therapy carried out previously with Enstilar spray foam. Secondary objectives Assess satisfaction with the treatment. Assess adherence to therapy. Evaluate the impact of various clinical and demographic factors on treatment adherence. Evaluate the efficacy of Wynzora cream therapy.

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.

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

Inclusion Criteria:

  • - Patients older than 18 years of age, of either sex; - Patients diagnosed with mild-to-moderate psoriasis (PASI and BSA <10) requiring monotherapy topical with Wynzora; - Patients who have stopped treatment with Enstilar foam for any reason for at least 30 days; and.
  • - Patients whose medical records are accessible and record all demographic parameters, anthropometric and clinical parameters during the treatment period.
  • - Signature of written informed consent;

    Exclusion Criteria:

    - Patients with palmoplantar, inverse, erythrodermic, guttate, and scalp psoriasis.
  • - Patients who are taking concomitant systemic therapies for psoriasis, such as.
cyclosporine, methotrexate, acitretin, phototherapy or biologic therapies.
  • - Women who are pregnant or planning to become pregnant.
  • - Patients with disabilities or other motor problems that could complicate self-medication.

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.

NCT06180473
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.

Lead Sponsor

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Principal Investigator

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

N/A
Principal Investigator Affiliation N/A
Agency Class

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

Other
Overall Status Not yet recruiting
Countries
Conditions

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

Psoriasis

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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