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

Evaluation of Tolerability, Efficacy and Adherence to Treatment With Wynzora Cream in Patients With Psoriasis Previously Treated With Enstilar Foam.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Rome, Italy
        • Policlinico Agostino Gemelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients diagnosed with psoriasis will be enrolled, who will be according to clinical practice will be prescribed treatment with Wynzora cream for 30 consecutive days, referring to the Dermatology and Venereology outpatient clinics of the Fondazione Policlinico Universitario A. Gemelli, IRCCS Rome

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
preference of wynzora cream
Time Frame: 1 month
Percentage of patients who prefer treatment with Wynzora compared with treatment with Enstilar at week 4 of use; preference for Wynzora will be assessed by considering a score of 3 or higher on question 5 of the PPQ questionnaire.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

March 31, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

December 12, 2023

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Actual)

December 22, 2023

Study Record Updates

Last Update Posted (Estimated)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 25, 2025

Last Verified

December 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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