J Drugs Dermatol. 2022 Jun 1;21(6):587-595. doi: 10.36849/JDD.6876.
Females aged ≥25 years may have acne with different etiology, presentation, burden, and treatment response than females 18–24 years. This post hoc analysis investigated efficacy and safety of tazarotene 0.045% lotion in females ≥18 years or ≥25 years of age.
In two phase 3 double-blind studies, participants 9 years of age and older with moderate-to-severe acne were randomized (1:1) to once-daily tazarotene 0.045% lotion or vehicle lotion for 12 weeks. Pooled data were analyzed for females aged ≥18 years (n=744) or ≥25 years (n=335). Assessments included inflammatory/noninflammatory lesion counts, treatment success (≥2-grade reduction from baseline in Evaluator’s Global Severity Score and score of 0 [clear] or 1 [almost clear]), Acne-Specific Quality of Life (Acne-QoL) questionnaire, treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability.
At week 12, tazarotene-treated females in both age groups had greater reductions from baseline versus vehicle in inflammatory (≥18 years: 60.6% vs 53.7% [P<0.01]; ≥25 years: 60.9% vs 57.3% [P>0.05]) and noninflammatory lesions (59.0% vs 48.4% and 61.1% vs 48.8%; P<0.01, both). Rates of treatment success were greater with tazarotene versus vehicle; this difference was significant for females ≥18 years. Acne-QoL improvements were similar across age groups and generally greater with tazarotene than vehicle. TEAEs were mostly mild to moderate in severity. No age-related trends for safety or tolerability were observed.
Tazarotene 0.045% lotion demonstrated comparable efficacy, improvement in quality of life, and safety in adult females aged ≥18 or ≥25 years with moderate-to-severe acne. This cosmetically elegant lotion is a well-studied and important treatment option for all patients, particularly adult females. J Drugs Dermatol. 2022;21(5):587-595. doi:10.36849/JDD.6876.
年龄≥25 岁的女性可能患有不同于 18-24 岁女性的病因、表现、负担和治疗反应的痤疮。本事后分析旨在评估他扎罗汀 0.045%乳剂在年龄≥18 岁或≥25 岁女性中的疗效和安全性。
在两项 3 期双盲研究中，9 岁及以上的中重度痤疮患者被随机（1:1）分为他扎罗汀 0.045%乳剂或赋形剂乳剂组，治疗 12 周。对年龄≥18 岁（n=744）或≥25 岁（n=335）的女性进行汇总数据分析。评估包括炎症/非炎症性皮损计数、治疗成功（与基线相比，评估者总体严重程度评分至少降低 2 级，评分 0[清除]或 1[几乎清除]）、痤疮特异性生活质量（Acne-QoL）问卷、治疗中出现的不良事件（TEAEs）和皮肤安全性/耐受性。
在第 12 周，两组年龄的他扎罗汀治疗女性的炎症性皮损（年龄≥18 岁：60.6%比 53.7%[P＜0.01]；年龄≥25 岁：60.9%比 57.3%[P＞0.05]）和非炎症性皮损（59.0%比 48.4%和 61.1%比 48.8%；P＜0.01，均）均较基线有更大的改善。与赋形剂相比，他扎罗汀的治疗成功率更高，且这一差异在年龄≥18 岁的女性中具有统计学意义。痤疮生活质量的改善在各年龄组相似，且他扎罗汀的改善通常优于赋形剂。TEAEs 大多为轻度至中度严重程度。未观察到与安全性或耐受性相关的年龄相关趋势。
他扎罗汀 0.045%乳剂在中重度痤疮的年龄≥18 或≥25 岁成年女性中表现出相似的疗效、生活质量改善和安全性。这种美观的乳剂是一种经过充分研究的重要治疗选择，尤其适用于成年女性。《皮肤病药物杂志》。2022；21（5）：587-595。doi：10.36849/JDD.6876.
