Dall'Oglio Federica, Tedeschi Aurora, Lacarrubba Francesco, Fabbrocini Gabriella, Skroza Nevena, Chiodini Paolo, Micali Giuseppe
Dermatology Clinic, University of Catania, Catania, Italy.
Section of Dermatology, Department of Clinical Medicine and Surgery, University Federico II of Naples, Naples, Italy.
J Cosmet Dermatol. 2021 Apr;20 Suppl 1(Suppl 1):28-31. doi: 10.1111/jocd.14098.
Topical azelaic acid (AzA) is a common treatment for mild/moderate inflammatory rosacea.
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.
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.
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.
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.
外用壬二酸（AzA）是治疗轻度/中度炎症性酒渣鼻的常用方法。
通过临床/仪器评估，评估一种含有15%AzA（抗炎/抗氧化/抗菌剂）与1%二氢燕麦酰胺D（抗炎/止痒）的新型配方乳膏在炎症性酒渣鼻治疗中的疗效和耐受性。
在这项多中心、前瞻性、开放标签试验中，招募了45例轻度/中度炎症性酒渣鼻患者，这些患者来自意大利卡塔尼亚、那不勒斯和罗马大学皮肤科诊所，被要求每天两次涂抹该乳膏，持续8周。在基线（T0）和8周（T1）时进行临床评估，评估内容包括：（1）研究者整体评估（IGA）评分，采用5分制（从0 = 无红斑/丘疹/脓疱到4 = 严重红斑/多个丘疹/脓疱）；（2）炎性皮损计数。在所有时间点，通过红斑定向数码摄影（EDDP）采用5分制（从0 = 无发红到4 = 严重发红）对红斑程度进行仪器评估。在8周时通过自我管理问卷评估耐受性。使用SAS 9版进行统计分析。
44例患者完成了研究。在第8周时，IGA评分[中位数从3（T0）降至1（T1）]和炎性皮损计数[中位数从8（T0）降至1（T1）]较基线均显著降低，同时红斑评分也显著降低[中位数从2（T0）降至1（T1）]。未记录到相关副作用。
我们的结果表明，这种新型无刺激性产品是轻度/中度炎症性酒渣鼻的有效治疗选择，并且EDDP能够更明确地评估红斑变化。
