{"title":"过氧化苯甲酰 4% 和烟酰胺 4% 固定浓度组合的成膜霜对轻度至中度痤疮受试者的疗效和皮肤微生物群调节作用:一项非赞助、前瞻性、评估者对照的试点试验","authors":"M. Puviani, K. Eisendle","doi":"10.3390/cosmetics11010025","DOIUrl":null,"url":null,"abstract":"Benzoyl peroxide (BPO) and niacinamide (Niac) are commonly used alone or in combination with other molecules in the treatment of acne. BPO and Niac in the same product could exert complementary and synergistic effects improving efficacy in acne. Furthermore, Niac could reduce some side effects of BPO, such as skin irritation and erythema. A film-forming cream product containing BPO 4% and Niac 4%, vehiculated in a mixture of polyvinyl alcohol (PVA) and perfluoropolyether (PFPE) has been recently developed (B-N cream). A 28-day, assessor-blinded pilot trial was conducted to evaluate the clinical efficacy, skin tolerability, sebum production, skin redness, and skin microbiome modulation of B-N cream in subjects with mild to moderate acne of the face. Twenty-two adult men and women with mild-to-moderate acne of the face participated in this trial, after their written informed consent. B-N cream was applied once daily in the evening. The use of B-N cream was associated with a statistically significant decrease in acne lesions after treatment in comparison with baseline (non-inflammatory lesions: −40%; inflammatory lesions: −43% and total lesions: −41%). The use of the cream was not associated with a skin barrier function alteration. The skin redness score (−11%) and the sebum production (−42%) were significantly reduced after treatment. The use of B-N cream determined a reduction in the relative abundance of the Actinobacteria phylum (Corynebacterium and Propionibacterium, from 56% to 47%) and a significant increase in the abundance of Bacteroidetes phylum (from 3% to 5.2%). In addition, the product was well tolerated. In conclusion, this film-forming, medical device cream was effective in subjects with mild-to-moderate acne, reducing acne lesions and sebum production without altering skin barrier function, offering good skin tolerability. Furthermore, this product exerts positive skin microbiome modulation effects.","PeriodicalId":10735,"journal":{"name":"Cosmetics","volume":null,"pages":null},"PeriodicalIF":3.4000,"publicationDate":"2024-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Skin Microbiome Modulation Effects of a Fixed-Concentration Combination of Benzoyl Peroxide 4% Plus Niacinamide 4% in a Film-Forming Cream in Subjects with Mild-to-Moderate Acne: A Non-Sponsored, Prospective, Assessor-Blinded, Pilot Trial\",\"authors\":\"M. Puviani, K. Eisendle\",\"doi\":\"10.3390/cosmetics11010025\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Benzoyl peroxide (BPO) and niacinamide (Niac) are commonly used alone or in combination with other molecules in the treatment of acne. BPO and Niac in the same product could exert complementary and synergistic effects improving efficacy in acne. Furthermore, Niac could reduce some side effects of BPO, such as skin irritation and erythema. A film-forming cream product containing BPO 4% and Niac 4%, vehiculated in a mixture of polyvinyl alcohol (PVA) and perfluoropolyether (PFPE) has been recently developed (B-N cream). A 28-day, assessor-blinded pilot trial was conducted to evaluate the clinical efficacy, skin tolerability, sebum production, skin redness, and skin microbiome modulation of B-N cream in subjects with mild to moderate acne of the face. Twenty-two adult men and women with mild-to-moderate acne of the face participated in this trial, after their written informed consent. B-N cream was applied once daily in the evening. The use of B-N cream was associated with a statistically significant decrease in acne lesions after treatment in comparison with baseline (non-inflammatory lesions: −40%; inflammatory lesions: −43% and total lesions: −41%). The use of the cream was not associated with a skin barrier function alteration. The skin redness score (−11%) and the sebum production (−42%) were significantly reduced after treatment. The use of B-N cream determined a reduction in the relative abundance of the Actinobacteria phylum (Corynebacterium and Propionibacterium, from 56% to 47%) and a significant increase in the abundance of Bacteroidetes phylum (from 3% to 5.2%). In addition, the product was well tolerated. In conclusion, this film-forming, medical device cream was effective in subjects with mild-to-moderate acne, reducing acne lesions and sebum production without altering skin barrier function, offering good skin tolerability. 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引用次数: 0
摘要
过氧化苯甲酰(BPO)和烟酰胺(Niac)通常单独使用或与其他分子结合使用来治疗痤疮。在同一种产品中添加过氧化苯甲酰(BPO)和烟酰胺(Niacinamide)可以发挥互补和协同作用,提高对痤疮的疗效。此外,Niac 还能减少 BPO 的一些副作用,如皮肤刺激和红斑。最近开发出了一种成膜乳膏产品(B-N 乳膏),其中含有 4% 的 BPO 和 4% 的烟酸,以聚乙烯醇(PVA)和全氟聚醚(PFPE)的混合物为载体。我们进行了一项为期 28 天的评估者盲法试验,以评估 B-N 乳霜对轻度至中度面部痤疮患者的临床疗效、皮肤耐受性、皮脂分泌、皮肤发红和皮肤微生物组调节作用。22 名患有轻度至中度面部痤疮的成年男女在获得书面知情同意后参加了此次试验。每天傍晚涂抹一次 B-N 霜。与基线值相比,使用 B-N 霜治疗后痤疮皮损的减少具有统计学意义(非炎症性皮损:-40%;炎症性皮损:-40%):非炎症性皮损:-40%;炎症性皮损:-4343%,皮损总数:-41%):-41%).使用该药膏与皮肤屏障功能的改变无关。治疗后,皮肤发红评分(-11%)和皮脂分泌(-42%)明显减少。使用 B-N 乳霜后,放线菌门(棒状杆菌和丙酸杆菌,从 56% 降至 47%)的相对数量减少,而类杆菌门的数量则显著增加(从 3% 增至 5.2%)。此外,该产品的耐受性良好。总之,这种成膜型医疗器械乳膏对轻度至中度痤疮患者有效,可减少痤疮皮损和皮脂分泌,同时不改变皮肤屏障功能,皮肤耐受性良好。此外,该产品还具有积极的皮肤微生物组调节作用。
Efficacy and Skin Microbiome Modulation Effects of a Fixed-Concentration Combination of Benzoyl Peroxide 4% Plus Niacinamide 4% in a Film-Forming Cream in Subjects with Mild-to-Moderate Acne: A Non-Sponsored, Prospective, Assessor-Blinded, Pilot Trial
Benzoyl peroxide (BPO) and niacinamide (Niac) are commonly used alone or in combination with other molecules in the treatment of acne. BPO and Niac in the same product could exert complementary and synergistic effects improving efficacy in acne. Furthermore, Niac could reduce some side effects of BPO, such as skin irritation and erythema. A film-forming cream product containing BPO 4% and Niac 4%, vehiculated in a mixture of polyvinyl alcohol (PVA) and perfluoropolyether (PFPE) has been recently developed (B-N cream). A 28-day, assessor-blinded pilot trial was conducted to evaluate the clinical efficacy, skin tolerability, sebum production, skin redness, and skin microbiome modulation of B-N cream in subjects with mild to moderate acne of the face. Twenty-two adult men and women with mild-to-moderate acne of the face participated in this trial, after their written informed consent. B-N cream was applied once daily in the evening. The use of B-N cream was associated with a statistically significant decrease in acne lesions after treatment in comparison with baseline (non-inflammatory lesions: −40%; inflammatory lesions: −43% and total lesions: −41%). The use of the cream was not associated with a skin barrier function alteration. The skin redness score (−11%) and the sebum production (−42%) were significantly reduced after treatment. The use of B-N cream determined a reduction in the relative abundance of the Actinobacteria phylum (Corynebacterium and Propionibacterium, from 56% to 47%) and a significant increase in the abundance of Bacteroidetes phylum (from 3% to 5.2%). In addition, the product was well tolerated. In conclusion, this film-forming, medical device cream was effective in subjects with mild-to-moderate acne, reducing acne lesions and sebum production without altering skin barrier function, offering good skin tolerability. Furthermore, this product exerts positive skin microbiome modulation effects.