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

NCT06180473 | Completed

• 1 other identifier: 6131
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

questionnaire OTHER

PPQ, TTAQ PTCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Policlinico Agostino Gemelli

Rome, Italy

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 22, 2023
• Study Start: January 1, 2024
• Primary Completion: March 31, 2024
• Study Completion: June 30, 2024
• Last Updated: September 2, 2025

Record last verified: 2023-12

Locations

IT (1)