Green Lawrence J, Del Rosso James Q, Tanghetti Emil A, Guenin Eric
J Drugs Dermatol. 2021 Jun 1;20(6):608-615. doi: 10.36849/JDD.2021.6070.
Two identical phase 3 trials (NCT03168321 and NCT03168334) and pooled post hoc analyses have established efficacy and safety of a polymeric tazarotene 0.045% lotion formulation in patients with moderate-to-severe acne. Presented here are post hoc analyses that further examine efficacy and safety of tazarotene 0.045% lotion by age and sex.
Patients aged ≥ 9 years with moderate-to-severe acne (score 3 or 4 on the Evaluator's Global Severity Score [EGSS]) were equally randomized to once-daily tazarotene 0.045% lotion or vehicle lotion for 12 weeks. Efficacy outcomes included inflammatory/noninflammatory lesion counts and treatment success (proportion of participants achieving ≥ 2-grade reduction from baseline in EGSS and score of 0 [clear] or 1 [almost clear]). Adolescent and adult females (n=1,013) and males (n=529) were subdivided into 3 age groups: 13–19, 20–29, and ≥30 years.
At week 12, large least-squares mean percent reductions in inflammatory and noninflammatory lesions were observed across all 3 tazarotene-treated age groups in males and females (range, -50.2% to -64.8%). Treatment success rates ranged from 23.6% to 38.4%. Across all efficacy assessments, significant differences between tazarotene and vehicle (P<0.05) were generally observed in the younger male and female participants (13–19 and 20–29). No notable age-related patterns were found for safety outcomes, though tazarotene-treated males of all age groups reported fewer adverse events than females.
Tazarotene 0.045% lotion is efficacious and well tolerated in female and male adolescents and adults with moderate-to-severe acne. J Drugs Dermatol. 2021;20(6):608-615. doi:10.36849/JDD.6070.
两项相同的3期试验（NCT03168321和NCT03168334）以及汇总的事后分析已证实，0.045%的聚合型他扎罗汀洗剂配方对中重度痤疮患者具有疗效和安全性。本文展示的是事后分析，进一步按年龄和性别研究0.045%他扎罗汀洗剂的疗效和安全性。
年龄≥9岁的中重度痤疮患者（评估者整体严重程度评分[EGSS]为3或4分）被随机分为两组，分别每日一次使用0.045%他扎罗汀洗剂或赋形剂洗剂，为期12周。疗效指标包括炎性/非炎性皮损计数和治疗成功情况（参与者EGSS较基线降低≥2级且评分为0[清除]或1[几乎清除]的比例）。青少年及成年女性（n = 1,013）和男性（n = 529）被细分为3个年龄组：13 - 19岁、20 - 29岁和≥30岁。
在第12周时，所有3个接受他扎罗汀治疗的男性和女性年龄组的炎性和非炎性皮损均出现了较大的最小二乘均值百分比降幅（范围为 - 50.2%至 - 64.8%）。治疗成功率在23.6%至38.4%之间。在所有疗效评估中，他扎罗汀组和赋形剂组之间的显著差异（P < 0.05）通常在较年轻的男性和女性参与者（13 - 19岁和20 - 29岁）中观察到。在安全性指标方面未发现明显的年龄相关模式，不过所有年龄组接受他扎罗汀治疗的男性报告的不良事件少于女性。
0.045%他扎罗汀洗剂对患有中重度痤疮的青少年及成年男性和女性有效且耐受性良好。《药物皮肤病学杂志》。2021；20(6)：608 - 615。doi:10.36849/JDD.6070。
