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Abstract：
OBJECTIVE: This study aimed to determine the efficacy and safety of fluocinolone acetonide, hydroquinone, and tretinoin (FAHT) cream for the treatment of moderate and severe facial melasma. The primary objective was assessment of clinical efficacy, instrumental measured efficacy, and integral therapeutic efficacy at the end of weeks 4 and 8.
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.
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.
摘要：
目的：本研究旨在确定氟轻松的疗效和安全性，对苯二酚,和维甲酸（FAHT）乳膏用于治疗中度和重度面部黄褐斑。主要目的是评估临床疗效，仪器测量的功效，以及在第4周和第8周结束时的整体治疗效果。
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。
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。
