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

Item request has been placed! ×
Item request cannot be made. ×
loading   Processing Request
Read Online Read More Add to Saved list
  • Additional Information
    • Subject Terms:
      NAPLES (Italy); ROME
    • Subject Terms:
      UNIVERSITA di Catania
    • 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. [ABSTRACT FROM AUTHOR]
    • Abstract:
      Copyright of Journal of Cosmetic Dermatology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)