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首页> 外文期刊>Journal of Cosmetics, Dermatological Sciences and Applications >Feasibility, Tolerability, Safety and Efficacy of a Pantothenic Acid Based Dietary Supplement in Subjects with Mild to Moderate Facial Acne Blemishes
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Feasibility, Tolerability, Safety and Efficacy of a Pantothenic Acid Based Dietary Supplement in Subjects with Mild to Moderate Facial Acne Blemishes

机译:基于泛酸的膳食补充剂在轻度至中度面部痤疮瑕疵患者中的可行性,耐受性,安全性和有效性

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摘要

Objective: It has been suggested that pantothenic acid may have antibacterial and skin softening activity. The aim of this study was to explore the feasibility, tolerability, safety and preliminary efficacy of oral administration of a dietary supplement containing pantothenic acid in healthy human males and females with mild to moderate facial acne vulgaris. Methods: An open-label, single arm study of healthy adults who had been previously diagnosed with mild to moderate acne vulgaris was performed. Subjects were asked to take the study agent, a dietary supplement containing pantothenic acid, for eight weeks. The primary endpoint of the study was to assess the feasibility of oral administration of the study agent in subjects over an eight week period. Safety and tolerability were measured utilizing the assessment of adverse events by the National Cancer Institute’s Common Criteria for Adverse Event Reporting. Secondary endpoints measuring the efficacy of an oral panthothetic acid dietary supplement for the treatment of mild to moderate facial acne utilized changes in the extent of global facial skin blemishes, assessment of quality of life utilizing the Dermatology Life Quality Index (DLQI) and analysis of questions about the subject's beliefs and attitudes towards skin care and lifestyle. Results: Eleven subjects were enrolled and ten completed the study (90.9%). There were no reported adverse events. Of the 10 evaluable subjects, the average age (mean ± SD) was 31.8 ± 8. Analysis of the global number of skin blemishes demonstrated a significant mean reduction in lesion count following the use of the study agent at week 8 (endpoint) (11.18 ± 6.38, p = 0.02) compared to the average number of baseline blemishes (20.45 ± 10.44). DLQI scores were significantly lower at week 8 vs. baseline (p = 0.0194). Conclusions: The results from this study indicated that the administration of a pantothenic based dietary supplement in healthy human adults with mild to moderate acne vulgaris is feasible, safe and well tolerated. Secondary analysis shows that administration of the study agent significantly reduced global facial blemishes. Further randomized, placebo-controlled trials are warranted.
机译:目的:已提出泛酸可能具有抗菌和软化皮肤的作用。这项研究的目的是探讨含有泛酸的膳食补充剂在健康的男性和女性轻度至中度寻常性痤疮中的口服可行性,耐受性,安全性和初步疗效。方法:进行了一项开放标签,单臂研究,对先前被诊断患有轻度至中度寻常型痤疮的健康成人进行。要求受试者服用本研究剂(一种含有泛酸的膳食补充剂)八周。该研究的主要终点是评估在八周的时间内对受试者口服研究药物的可行性。安全性和耐受性是根据美国国家癌症研究所的不良事件报告通用标准对不良事件进行评估而得出的。次要终点是测量口服泛酸饮食补充剂治疗轻度至中度痤疮的功效,该方法利用了全球面部皮肤瑕疵程度的变化,利用皮肤病生活质量指数(DLQI)评估生活质量和问题分析关于受试者对皮肤护理和生活方式的信念和态度。结果:招募了11名受试者,其中10名完成了研究(90.9%)。没有报告不良事件。在10位可评估的受试者中,平均年龄(平均值±SD)为31.8±8。对皮肤瑕疵的总体分析表明,在第8周(终点)使用研究药物后,皮损计数显着平均下降(11.18)。 ±6.38,p = 0.02),而基线瑕疵的平均数量为(20.45±10.44)。与基线相比,第8周的DLQI得分显着降低(p = 0.0194)。结论:这项研究的结果表明,以泛酸为基础的膳食补充剂在轻度至中度寻常痤疮的健康成人中给药是可行,安全且耐受性良好的。次要分析表明,研究药物的给药显着减少了整体面部斑点。有必要进行进一步的随机,安慰剂对照试验。

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