METHODS: A total of 233 subjects were randomly allocated (1:1 ratio) to receive topically administered FAHT cream (n = 117) or placebo (n = 116) once nightly for 8 weeks. Observed side effects were documented throughout.
RESULTS: In the per protocol set (PPS; those subjects who met all requirements of the protocol), the integral therapeutic efficacy rate of FAHT cream on moderate and severe melasma was 68.57% (vs. placebo, 0.94%), the clinical effective rate of FAHT cream was 74.29 % (vs. placebo, 0.94%), and the instrumental measure efficacy of FAHT cream was 71.43% (vs. placebo, 6.60%). The difference in efficacy between the two groups was statistically significant (p < 0.001). In the full analysis set (FAS; the PPS and those subjects who were lost to follow-up but received at least one study treatment), the integral therapeutic efficacy rate of FAHT cream was 64.60% (vs. placebo, 0.88%), the clinical effective rate of FAHT cream was 69.91% (vs. placebo, 0.88%), and the instrumental measure efficacy of FAHT cream was 69.03 % (vs. placebo, 7.08%). The difference in efficacy between the two groups was statistically significant (p < 0.001). Of 113 subjects in the FAHT group, 34 (30.1%) reported adverse effects. Most of the pathological adverse effects were mild and resolved with either continuous treatment or discontinuation. Of 113 subjects in the placebo group, three (2.6%) reported mild adverse effects. No severe adverse effects or other abnormal clinical results were associated with the study treatment.
CONCLUSIONS: FAHT cream is efficacious, well tolerated, and has a high margin of safety for the treatment of moderate and severe melasma in the Chinese population.
方法:总共233名受试者被随机分配(1:1比例),每晚接受一次FAHT乳膏(n=117)或安慰剂(n=116),持续8周。全程记录观察到的副作用。
结果:在每个方案集(PPS;满足方案所有要求的受试者)中,FAHT乳膏对中重度黄褐斑的整体疗效为68.57%(vs.安慰剂,0.94%),FAHT乳膏的临床有效率为74.29%(vs.安慰剂,0.94%),FAHT乳膏的仪器测量功效为71.43%(vs.安慰剂,6.60%)。两组疗效差异有统计学意义(p<0.001)。在完整的分析集(FAS;PPS和那些失去随访但接受至少一项研究治疗的受试者)中,FAHT乳膏的整体疗效率为64.60%(vs.安慰剂,0.88%),FAHT乳膏的临床有效率为69.91%(vs.安慰剂,0.88%),FAHT乳膏的仪器测量功效为69.03%(vs.安慰剂,7.08%)。两组疗效差异有统计学意义(p<0.001)。在FAHT组的113名受试者中,34例(30.1%)报告了不良反应。大多数病理不良反应是轻微的,可以通过连续治疗或停药解决。在安慰剂组的113名受试者中,3例(2.6%)报告了轻度不良反应.没有与研究治疗相关的严重不良反应或其他异常临床结果。
结论:FAHT乳膏有效,良好的耐受性,并且在中国人群中治疗中度和重度黄褐斑具有很高的安全边际。