Fabbrocini Gabriella, Ferrillo Maria, Donnarumma Marianna, Papale Angela, Pinto Daniela, Rinaldi Fabio
Department of Clinical Medicine and Surgery, Section of Dermatology, University Hospital Federico II of Naples, Naples, Italy.
HMAP, Human Microbiome Advanced Project, Via Pelagio Palagi, 2, 20129, Milan, Italy.
Dermatol Ther (Heidelb). 2022 Aug;12(8):1835-1845. doi: 10.1007/s13555-022-00767-1. Epub 2022 Jul 21.
Several options are available to treat acne lesions, including topical benzoyl peroxide, topical retinoids, topical antibiotics, oral antibiotics, hormonal therapy, isotretinoin, and procedural therapies, such as light and laser therapies, although these cause side effects. This study aimed to establish the efficacy and tolerability of a class IIa medical device containing lactic acid, azelaic acid/polyglyceryl-3 copolymer, azelamidopropyl dimethyl amine, and bifida ferment lysate for the treatment of mild and moderate acne lesions.
A randomized, double-blind, placebo-controlled, multicentric study was carried out in which 60 persons of both genders aged ≥ 16 years affected by mild or moderate acne were enrolled. Each person used the product twice daily for 2 months. The clinical score (classified as absent, mild, moderate, and severe) of lesions such as blackheads, whiteheads, papules and pustules, erythema, desquamation, sebum secretion, and porphyrins production by a wood lamp was evaluated on the basis of a dermatologist's visual assessment at baseline (t) and after 2 months of treatment (t), and the results were compared between groups. Digital photographic images were also taken.
Sixty subjects concluded the trial. It was observed that subjects treated with the medical device (group I) showed overall improvement in the analyzed acne lesions compared with placebo (group II) after 2 months of treatment. The efficacy of the treatment was also expressed as partial and total clearance. The medical device produced higher percentages of both partial and total clearance in all analyzed parameters, compared with the placebo group. The study was safe and well tolerated.
It was observed that the participants showed an overall improvement of the analyzed lesions in comparison with the placebo group, without adverse events during the trial. Hence, the medical device was found to be safe and effective in the treatment of mild or moderate acne.
治疗痤疮皮损有多种选择，包括外用过氧化苯甲酰、外用维甲酸、外用抗生素、口服抗生素、激素疗法、异维甲酸以及光疗和激光疗法等程序性治疗，不过这些治疗都会产生副作用。本研究旨在确定一种含有乳酸、壬二酸/聚甘油 -3 共聚物、壬酰氨基丙基二甲基胺和双歧杆菌发酵溶胞产物的 IIa 类医疗器械治疗轻中度痤疮皮损的疗效和耐受性。
开展了一项随机、双盲、安慰剂对照、多中心研究，纳入了 60 名年龄≥16 岁、患有轻中度痤疮的男女受试者。每人每天使用该产品两次，持续 2 个月。根据皮肤科医生在基线（t0）和治疗 2 个月后（t2）的视觉评估，对黑头、白头、丘疹和脓疱、红斑、脱屑、皮脂分泌以及伍德灯检测的卟啉生成等皮损的临床评分（分为无、轻度、中度和重度）进行评估，并在组间比较结果。还拍摄了数码照片。
60 名受试者完成了试验。观察到，与安慰剂组（II 组）相比，使用该医疗器械治疗的受试者（I 组）在治疗 2 个月后，所分析的痤疮皮损总体有改善。治疗效果也以部分清除和完全清除来表示。与安慰剂组相比，该医疗器械在所有分析参数中产生的部分清除和完全清除的百分比更高。该研究安全且耐受性良好。
观察到，与安慰剂组相比，参与者所分析的皮损总体有改善，试验期间无不良事件。因此，发现该医疗器械在治疗轻中度痤疮方面安全有效。
