- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06180473
Evaluation of Tolerability, Efficacy and Adherence to Treatment With Wynzora Cream (psowyn)
August 25, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
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
-
-
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Rome, Italy
- Policlinico Agostino Gemelli
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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
Additional Relevant MeSH Terms
- Skin Diseases, Papulosquamous
- Skin Diseases
- Skin and Connective Tissue Diseases
- Psoriasis
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- 6131
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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