Manhattan Medical Research, New York, USA.
Dermatol Ther (Heidelb). 2014 Jun;4(1):93-101. doi: 10.1007/s13555-014-0052-3. Epub 2014 May 16.
The purpose of this study was to determine the safety, tolerability and effectiveness of daily administration of an orally administered pantothenic acid-based dietary supplement in men and women with facial acne lesions.
A randomized, double-blind, placebo-controlled study of adults previously diagnosed with mild to moderate acne vulgaris was performed. Subjects were randomized to the study agent, a pantothenic acid-based dietary supplement, or a placebo for 12 weeks (endpoint). The primary outcome of the study was the difference in total lesion count between the study agent group versus the placebo group from baseline to endpoint. Secondary measurements included differences in mean non-inflammatory and inflammatory lesions, Investigators Global Assessment and Dermatology Life Quality Index (DLQI) scores between the two groups. Investigator assessment of overall improvement and skin photographs were also taken. Safety and tolerability endpoints were the assessment of adverse events and measurement of serum complete blood count and hepatic function.
Forty-eight subjects were enrolled and 41 were evaluable. There was a significant mean reduction in total lesion count in the pantothenic acid group versus placebo at week 12 (P = 0.0197). Mean reduction in inflammatory lesions was also significantly reduced and DLQI scores were significantly lower at week 12 in the pantothenic acid group versus placebo. The study agent was safe and well tolerated.
The results from this study indicate that the administration of a pantothenic acid-based dietary supplement in healthy adults with facial acne lesions is safe, well tolerated and reduced total facial lesion count versus placebo after 12 weeks of administration. Secondary analysis shows that the study agent significantly reduced area-specific and inflammatory blemishes. Further randomized, placebo-controlled trials are warranted.
本研究旨在确定每日口服泛酸基膳食补充剂在患有面部痤疮病变的男性和女性中的安全性、耐受性和有效性。
对先前被诊断为轻度至中度寻常痤疮的成年人进行了一项随机、双盲、安慰剂对照研究。受试者被随机分配到研究药物（泛酸基膳食补充剂）或安慰剂组，为期 12 周（终点）。该研究的主要结局是研究药物组与安慰剂组从基线到终点的总病变计数差异。次要测量包括两组之间平均非炎性和炎性病变、研究者总体评估和皮肤病生活质量指数（DLQI）评分的差异。还对两组的整体改善和皮肤照片进行了评估。安全性和耐受性终点是评估不良事件和测量血清全血细胞计数和肝功能。
共有 48 名受试者入组，41 名可评估。在第 12 周时，泛酸组的总病变计数与安慰剂组相比有显著的平均降低（P=0.0197）。泛酸组的炎性病变的平均减少也显著降低，且 DLQI 评分在第 12 周时也显著低于安慰剂组。研究药物安全且耐受性良好。
这项研究的结果表明，在患有面部痤疮病变的健康成年人中，口服泛酸基膳食补充剂是安全的，耐受性良好的，并且在 12 周的治疗后与安慰剂相比，总面部病变计数降低。二次分析显示，研究药物显著减少了特定区域和炎症性瑕疵。需要进一步进行随机、安慰剂对照试验。
