含青蒿挥发油的护肤品在敏感性皮肤人群中的效果及安全性OA
Clinical observation on the efficacy and safety of skin care product containing artemisia naphtha in individuals with sensitive skin
目的 评价含青蒿挥发油的护肤品在敏感性皮肤人群中的功效性及安全性.方法 采用单中心、使用前后自身对照的临床试验,对31例敏感性皮肤受试者面部外用含青蒿挥发油的护肤品,每日2次,连续使用4周.在使用前及使用第7、14、28天分别对受试者皮肤进行生理功能测试、VISIA-CR拍照及乳酸刺痛试验;采用16S rRNA基因测序技术进行皮肤表面微生态分析;同时进行医生评估和受试者自评.结果 使用第7、14、28天:医生评估红斑评分显著低于使用前基线评分(P<0.05),受试者自评瘙痒、刺痛、灼热、紧绷、潮红、敏感度评分亦较基线评分不同程度的下降(均P<0.05),受试者皮肤红色区a值均下降,显著低于基线值(t值分别为3.09、2.86、2.55,P值分别为0.004、0.008、0.016);皮肤红斑指数均显著低于基线值(均P<0.05).第7和28天,受试者皮肤水分含量均显著高于基线值(均P<0.05);TEWL值与基线值相比有下降趋势,第14天时显著低于基线值(P<0.05),使用试验产品后不同时间点皮肤弹性参数R2、R5及紧致度参数F4与基线值相比差异无统计学意义(均P>0.05).使用后第14、28天,受试者乳酸刺痛试验评分均显著低于基线评分(Z值分别为-4.12、-5.01,均P<0.001).微生物物种组成α多样性指标Chao1、ACE指数在第14天时显著高于基线值(x2值分别为-4.03、-4.13,均P<0.001);β多样性分析显示,4个测试时间点样本未能各自聚集成簇,组成结构差异无统计学意义.试验过程中均未出现不良反应.结论 含青蒿挥发油的护肤品对敏感性皮肤人群具有较高的安全性,有助于恢复皮肤屏障功能,增加角质层含水量,减少经皮水分丢失;缓解皮肤瘙痒、刺痛、灼热、紧绷、潮红等症状,降低乳酸刺痛试验评分;增加面部皮肤微生物群组成的丰富性和多样性.
Objective To evaluate the safety and efficacy of skin care product containing arte-misia naphtha in individuals with sensitive skin.Methods A single-center and self-controlled(before and after application)clinical trial was conducted in 31 subjects with sensitive skin.Test product was applied to the face of the subjects twice daily for 4 weeks.Measurement of physiologi-cal function,VISIA-CR photography and lactic acid test were carried out on the skin before and on the days 7,14,28 of the trial.16S rRNA gene sequencing technology was used to analyze the mi-croecological diversity of the skin surface meanwhile physician and subject'self-assessments were performed.Results Physician assessment scores for erythema were decreased at all three follow-up visits(P<0.05 vs.baseline).The subjects'self-assessments of itching,tingling,burning,tightness,flushing and sensitivity scores were also decreased(all P<0.05 vs.baseline).The skin a*values were decreased significantly(all P<0.05 vs.baseline).Similarly,erythema in-dex was significantly decreased(all P<0.05 vs.baseline).Moreover,stratum corneum hydra-tion levels were significantly increased on D7 and D28(all P<0.05 vs.baseline).The transepi-dermal water loss rates tended to decrease,and were significantly different between the baseline and day 14(P<0.05).In contrast,the skin elasticity and firmness parameters were not changed significantly.Furthermore,lactic acid scores were decreased significantly on D14 and D28(all P<0.001 vs.baseline).Additionally,there was a tendency of increases in alpha diversity indices ACE and Chaol on days D7 and D14,with a significant increase on day 14(P<0.05 vs.base-line).Beta diversity analysis showed that the four groups of samples failed to gather into clusters,and the differences in composition structure were not significant.No adverse reactions were ob-served during the trial.Conclusions Skin care product containing artemisia naphtha is safe for individuals with sensitive skin and improves multiple clinical signs and symptoms of sensitive skin,including acceleration of the skin barrier recovery,elevation in stratum corneum hydration,reduc-tion in transepidermal water loss rates and lactate stinging test score,alleviation of itching,ting-ling,burning,tightness and flushing,and increases in the richness and diversity of facial skin microbiota.
王莎;李佳佳;李玲;敖瑜灿;杨宇阁;黄虎;刁庆春;陶侃;吕静;江阳;郭莉莉;秦紫嫣;葛梦茹
重庆市中医院,重庆 400011重庆市中医院,重庆 400011重庆市中医院,重庆 400011重庆市中医院,重庆 400011上海昆药生物科技有限公司,上海 201400上海昆药生物科技有限公司,上海 201400重庆市中医院,重庆 400011上海昆药生物科技有限公司,上海 201400重庆市中医院,重庆 400011重庆市中医院,重庆 400011上海昆药生物科技有限公司,上海 201400上海昆药生物科技有限公司,上海 201400上海昆药生物科技有限公司,上海 201400
敏感性皮肤青蒿挥发油护肤品安全性功效性微生态
sensitive skinartemisia naphthaskin caresafetyefficacymicroecol-ogy
《皮肤性病诊疗学杂志》 2024 (2)
67-76,10
重庆市药品不良反应监测中心科研项目(H0120230001)
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