Topical 15% azelaic acid (AzA) may be a valid therapeutic option for patients with mild to moderate inflammatory rosacea, according to study findings published in the Journal of Cosmetic Dermatology.
The open-label, prospective clinical trial assessed the efficacy and tolerability of a formulation cream containing 15% AzA combined with 1% dihydroavenanthramide D for patients with inflammatory rosacea.
A total of 45 adults with mild to moderate inflammatory rosacea were enrolled at multiple centers in Italy from September 2018 to April 2019. The study duration was up to 8 weeks with a follow-up of at least 4 weeks, and participants were instructed to apply the cream twice daily for 8 weeks.
Clinic parameter scores regarding erythema and inflammatory lesions at week 8 were the primary endpoints for efficacy. The secondary endpoint was tolerability at the end of the study. A clinical evaluation was conducted at baseline (T0) and at week 8 (T1) with use of the Investigator Global Assessment (IGA) score according to a 5-point scale, which ranged from 0 (no erythema, papules, and/or pustules) to 4 (severe erythema: numerous small and/or large papules/pustules), and with the inflammatory lesion count (ILC).
Erythema-directed digital photography (EDDP) was used to assess erythema degree using a 5-point scale that ranged from 0 (no erythema) to 4 (severe erythema). A self-administered questionnaire was also used to assess tolerability at week 8, which included erythema, dryness, stinging, burning, and itch.
A total of 44 patients (mean age, 46.1 ± 12 years; range, 18-70 years; 34 women) completed the study. At week 8, the investigators found a significant decrease from baseline in IGA scores (median of 3 at T0 to 1 at T1; P < .001) and ILC (median of 8 at T0 to 1 at T1; P < .001), as well as a significant reduction in EDDP scores (median of 8 at T0 to 1 at T1; P < .001). Severe erythema was observed in 1 patient, and product tolerability was rated as excellent in 90% of patients.
“Our study suggests that this new topical 15% AzA formulation may represent a valid therapeutic option for mild-to-moderate inflammatory rosacea that undoubtedly deserves attention,” stated the researchers.
Dall’Oglio F, Tedeschi A, Lacarrubba F, et al. A novel azelaic acid formulation for the topical treatment of inflammatory rosacea: A multicentre, prospective clinical trial. J Cosmet Dermatol. 2021;20(Suppl 1):28-31. doi: 10.1111/jocd.14098