Clinical Research Directory

Efficacy and Tolerability Evaluation of a Novel Dermo-cosmetic Product for Mild-to-moderate Acne

Sponsor: ISISPHARMA

Summary

The goal of this non-interventional, observational study is to evaluate the real-world efficacy and tolerance of a novel dermocosmetic cream containing 15% Azelaic acid and a complex of active ingredients (α-AZ cream) in patients with mild-to-moderate acne treated in routine clinical practice. The main questions addressed are: * Does the product show good clinical efficacy on acne and inflammatory lesions in standard practice? * Does the product offer good cutaneous tolerance during routine use? Patients are observed across three routine care cohorts according to their prescribed/recommended regimen: α-AZ cream alone (Group 1), α-AZ cream combined with an oral acne treatment (Group 2), or a topical acne treatment (Group 3), over a period of 84 days. The study observes and compares real-world outcomes and tolerance across these standard care management approaches without imposing any protocol-driven treatment allocation. Researchers will compare the new dermocosmetic cream with group 2 and group 3 to see if the study product shows an equivalent or a better tolerance/efficiency than the drug treatment.

Official title: A Pilot Study on the Comparative Efficacy and Tolerability of a Novel Dermo-cosmetic Cream With 15% Azelaic Acid for Mild to Moderate Acne: A New Approach to Acne Treatment

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