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

Overview

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.

Background and study aims: Acne vulgaris is a prevalent skin condition, especially among teenagers and young adults. Traditional treatments, including topical retinoids and antibiotics, often lead to side effects that reduce adherence and effectiveness.The study aimed to evaluate the efficacy and tolerability of a novel dermo-cosmetic cream containing 15% azelaic acid in alleviating acne burden in patients with mild-to-moderate acne. Study Nature and Non-Intervention: This is a purely observational study. Treatment choices (including α-AZ cream and/or standard anti-acne medications) are made solely at the discretion of the treating physician in accordance with routine medical practice, independently of and prior to patient inclusion in the study. Participation in the study does not alter the patient's therapeutic care, and no protocol-mandated interventions or additional invasive procedures are imposed. Who can participate? Patients aged 12 years and older presenting with mild-to-moderate acne managed in routine clinical practice. What does the study involve? Observational evaluations are conducted during routine clinical visits (baseline and follow-up visits) to record acne severity (comedones, papules, pustules, and nodules) and total number of inflammatory lesions (red and brown marks). Treating physicians record routine product tolerability, and subjects complete a Quality of Life (QoL) questionnaire during their standard care follow-up. What are the possible benefits and risks of participating? Participants receive standard care for their condition, which aims to improve acne severity. Since treatment is prescribed within standard clinical practice, risks do not differ from normal routine care. Where is the study run from? The study is conducted in two private dermatologists' offices in Romania. When is the study starting and how long is it expected to run for? September 2022 to September 2023. Who is funding the study? ISISPHARMA (France).