A novel azelaic acid formulation for the topical treatment of inflammatory rosacea: A multicentre, prospective clinical trial.

Background Topical azelaic acid (AzA) is a common treatment for mild/moderate inflammatory rosacea. Aims To assess the efficacy and tolerability of a novel formulation cream containing 15% AzA (anti-inflammatory/anti-oxidant/anti-microbial agent) combined with 1% dihydroavenanthramide D (anti-inflammatory/anti-itch) in inflammatory rosacea using clinical/instrumental evaluation. Methods In this multicentre, prospective, open-label trial, 45 patients with mild/moderate inflammatory rosacea enrolled at the Dermatology Clinic of the University of Catania, Naples, and Rome (Italy) were instructed to apply the cream twice daily for 8 weeks. Clinical evaluation was performed at baseline (T0) and at 8 weeks (T1) by (1) Investigator Global Assessment (IGA) score based on a 5-point scale (from 0 = clear/no erythema/papules/pustules to 4 = severe erythema/several papules/pustules) and (2) inflammatory lesions count. Instrumental evaluation of erythema degree was performed by erythema-directed digital photography (EDDP) by a 5-point scale (from 0 = no redness to 4 = severe redness) at all time points. Tolerability was assessed by a self-administered questionnaire at 8 weeks. Statistical analysis was performed using SAS version 9. Results Forty-four patients completed the study. At week 8, a significant decrease in baseline of IGA scores [median from 3 (T0) to 1 (T1)] and inflammatory lesions count [median from 8 (T0) to 1 (T1)] was recorded along with a significant reduction of erythema scores [median from 2 (T0) to 1 (T1)]. No relevant side effects were recorded. Conclusions Our results suggest that this new non-irritating product represents a valid therapeutic option for mild/moderate inflammatory rosacea, and EDDP is able to provide a more defined evaluation of erythema changes.