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季节对0.045%他扎罗汀洗剂治疗痤疮疗效和耐受性的影响

Influence of Season on Efficacy and Tolerability of Tazarotene 0.045% Lotion for the Treatment of Acne.

作者信息

Tan Jerry, Draelos Zoe D, Gooderham Melinda J, Alexis Andrew F, Graber Emmy, Keri Jonette, Woolery-Lloyd Heather C, Harper Julie C, Cook-Bolden Fran E, Konda Adarsh, Tanghetti Emil A

机构信息

Dr. Tan is with the Schulich School of Medicine and Dentistry at Western University in Ontario, Canada.

Dr. Draelos is with Dermatology Consulting Services, PLLC in High Point, North Carolina.

出版信息

J Clin Aesthet Dermatol. 2023 Sep;16(9):42-45.

PMID:37720201
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10503937/
Abstract

OBJECTIVE

The condition of the skin can vary due to weather fluctuations. Therefore, this analysis evaluated efficacy and safety of tazarotene 0.045% lotion in warmer versus colder months.

METHODS

In two Phase III, double-blind, 12-week studies, participants aged nine years or older with moderate-to-severe acne were randomized 1:1 to once-daily tazarotene or vehicle lotion. The pooled population (N=1,614) was stratified by randomization date (warmer=May to September; colder=October to April). Evaluations included inflammatory/noninflammatory lesion counts, treatment success, adverse events, and safety/tolerability.

RESULTS

Tazarotene 0.045% lotion was similarly efficacious over colder and warmer months. Compared with vehicle, tazarotene demonstrated significantly greater least-squares mean absolute reductions from baseline to Week 12 in inflammatory (colder/warmer tazarotene vs. vehicle: -16.6/-15.8 vs. -13.2/-12.9) and noninflammatory lesions (-23.2/-22.6 vs. -17.5/-15.1); treatment success rates were also significantly higher (30.1/30.8% vs. 18.2/17.6%) (<0.001, all). No strong seasonal trends in safety were observed, though tazarotene led to slightly more discontinuations (3.4% vs. 1.9%) and related adverse events (12.0% vs. 10.3%) in colder versus warmer months. Transient increases in scaling, erythema, and itching at Weeks 2 to 8 of tazarotene treatment were slightly higher in colder versus warmer months but returned to baseline/improved by Week 12.

LIMITATIONS

Geographical variation across study sites can lead to varying temperatures and humidity within the same months.

CONCLUSION

Tazarotene 0.045% lotion was efficacious and well tolerated for acne treatment, regardless of season. Year-round tolerability of tazarotene 0.045% lotion may be due to its lower tazarotene concentration and polymeric emulsion technology, which simultaneously delivers moisturizers/humectants/emollients to skin.

摘要

目的

皮肤状况会因天气波动而有所不同。因此,本分析评估了0.045%他扎罗汀洗剂在较温暖月份与较寒冷月份的疗效和安全性。

方法

在两项III期双盲、为期12周的研究中,年龄在9岁及以上的中度至重度痤疮患者按1:1随机分配,每日一次使用他扎罗汀或赋形剂洗剂。汇总人群(N = 1614)按随机分组日期分层(较温暖月份 = 5月至9月;较寒冷月份 = 10月至4月)。评估包括炎性/非炎性皮损计数、治疗成功率、不良事件以及安全性/耐受性。

结果

0.045%他扎罗汀洗剂在较寒冷和较温暖月份的疗效相似。与赋形剂相比,他扎罗汀在第12周时从基线的最小二乘均值绝对减少量在炎性皮损(较寒冷/较温暖月份他扎罗汀组与赋形剂组:-16.6/-15.8对-13.2/-12.9)和非炎性皮损方面(-23.2/-22.6对-17.5/-15.1)显著更大;治疗成功率也显著更高(30.1/30.8%对18.2/17.6%)(均P<0.001)。未观察到明显的安全性季节性趋势,不过在较寒冷月份与较温暖月份相比,他扎罗汀导致的停药略多(3.4%对1.9%)以及相关不良事件略多(12.0%对10.3%)。他扎罗汀治疗第2至8周时脱屑、红斑和瘙痒的短暂增加在较寒冷月份略高于较温暖月份,但在第12周时恢复至基线水平或有所改善。

局限性

研究地点的地理差异可能导致同一月份内温度和湿度有所不同。

结论

0.045%他扎罗汀洗剂治疗痤疮有效且耐受性良好,无论季节如何。0.045%他扎罗汀洗剂全年的耐受性可能归因于其较低的他扎罗汀浓度以及聚合物乳液技术,该技术可同时为皮肤提供保湿剂/吸湿剂/润肤剂。

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