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

Psoriasis Clinical Trial

— psowyn  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06180473
• Other study ID #: 6131
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Other:
• questionnaire
PPQ, TTAQ PTCS

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preference of wynzora cream	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