通过随机、对照、临床试验对 1 款沐浴露的祛痘功效及其安全性进行测试,旨在探索身体护理类产品祛痘功效宣称的评价方法.将 60 例背部寻常痤疮患者随机分为试验组和对照组,每组各30 例,通过临床痤疮评估、安全性试用评估、仪器测试、真菌检测方法对产品的功效和安全性进行评价.试验组连续使用产品4 周后,试验组的炎性丘疹计数、白头粉刺计数、瘙痒评分、炎性丘疹体积、皮肤油脂、真菌孢子量与基础值相比均显著减少.与对照组相比,试验组单位面积内孢子量净改变值显著优于对照组.建议对身体护理产品的祛痘功效建立全面评估手段,综合临床痤疮计数评估、安全性试用评价、仪器测试(炎性丘疹体积,皮肤油脂)、真菌检测等多维度评价方法,全面有效地反映身体护理类产品的祛痘功效.
A randomized,controlled and clinical trial was conducted to test the anti-acne efficacy and safety of a body wash,aiming to established an in vivo method for evaluating the anti-acne efficacy of body care products.Sixty patients who had acne vulgaris in the back were randomly divided into test group and control group,30 cases in each group.The efficacy and safety of the body wash were evaluated by clinical assessment,safety assessment,instrumental test and fungi detection.Compared to the control group,numbers of inflammatory papules,whiteheads,itching score,volumes of inflammatory papules,sebum,and amount of fungi spores were significantly decreased at 4 weeks in the test group.Futhermore,the net change of fungi spores in the test group was significantly better than that in the control group.A comprehensive evaluation for the anti-acne efficacy of body care products was recommended.The combination of clinical assessment,safety assessment,instrumental test and fungi detection can evaluate the anti-acne efficacy of body care products comprehensively and effectively.