Goldberg David J
Skin Laser and Surgery Specialists of New York and New Jersey.
J Clin Aesthet Dermatol. 2016 Dec;9(12):13-20. Epub 2016 Dec 1.
To evaluate the efficacy and safety of a new topical silicone gel for the early intervention in the management of scars. In this 12-week, observational study, healthy subjects (n=15) with an accessible linear or hypertrophic scar were given the test product and instructed to apply twice daily. Subjects returned 14, 28, 56, and 84 days later for evaluation and recording of adverse events. Private practice of the author. Eligible subjects had a scar with a Vancouver Scar Scale total score ≥3 at baseline. Improvement was evaluated by the Vancouver Scar Scale and Observer Scar Assessment Scale at baseline and at four follow-up visits. The median total Vancouver Scar Scale score and median total Observer Scar Assessment Scale score decreased significantly from baseline at each visit, showing rapid and continuing improvement in the appearance of the scars. For Vancouver Scar Scale, significant differences of individual parameters from baseline began at 28 days for pliability and height, 56 days for vascularity, and 84 days for pigmentation. For Observer Scar Assessment Scale parameters, significant differences from baseline began at 14 days and continued until 84 days for vascularization, thickness, and pigmentation. Pain and pruritis scores were low at each visit. Overall, 84.6 percent of subjects rated the treatment as excellent, very good, or good after three months of treatment. No adverse events were reported. The test product improved the appearance of scars after three months of twice-daily treatment and without adverse events.
评估一种新型外用硅胶凝胶在瘢痕管理早期干预中的疗效和安全性。在这项为期12周的观察性研究中,对15名有可触及线性或增生性瘢痕的健康受试者给予受试产品,并指导其每天涂抹两次。受试者在14天、28天、56天和84天后返回进行不良事件的评估和记录。作者的私人执业。符合条件的受试者在基线时温哥华瘢痕量表总分≥3。在基线和四次随访时通过温哥华瘢痕量表和观察者瘢痕评估量表评估改善情况。每次随访时,温哥华瘢痕量表总分中位数和观察者瘢痕评估量表总分中位数均较基线时显著降低,表明瘢痕外观迅速且持续改善。对于温哥华瘢痕量表,柔韧性和高度在28天、血管分布在56天、色素沉着在84天开始出现与基线相比的个体参数显著差异。对于观察者瘢痕评估量表参数,血管化、厚度和色素沉着与基线相比的显著差异在14天开始出现,并持续到84天。每次随访时疼痛和瘙痒评分均较低。总体而言,84.6%的受试者在治疗三个月后将治疗评为优秀、非常好或良好。未报告不良事件。受试产品在每天涂抹两次治疗三个月后改善了瘢痕外观且无不良事件。