A novel azelaic acid formulation for the topical treatment of inflammatory rosacea: A multicentre, prospective clinical trial. (1st May 2021)

• Record Type: Journal Article
• Authors: Dall'Oglio, Federica; Tedeschi, Aurora; Lacarrubba, Francesco; Fabbrocini, Gabriella; Skroza, Nevena; Chiodini, Paolo; Micali, Giuseppe
• Is Part Of: Journal of cosmetic dermatology. Volume 20(2021)Supplement 1
• Page Start: 28
• Page End: 31
• Publication Date: 2021-05-01
• Subjects: azelaic acid -- rosacea -- topical treatments; Skin -- Diseases -- Treatment -- Periodicals; Lasers in surgery -- Periodicals; Skin -- Pathophysiology -- Periodicals; Surgery, Plastic -- Periodicals; 616.5
• DOI: 10.1111/jocd.14098
• Languages: English
• ISSNs: 1473-2130

Abstract

Abstract: 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.