Tanghetti Emil A., Werschler William P., Lain Terry, Guenin Eric, Martin Gina, Pillai Radhakrishnan
J Drugs Dermatol. 2020 Jan 1;19(1):70-77. doi: 10.36849/JDD.2020.3977.
Tazarotene has been extensively studied in clinical trials and is widely used to treat acne vulgaris (acne), with data suggesting that is one of the most potent topical retinoids. Irritation from the cream, foam, and gel formulations has limited its use in clinical practice. OBJECTIVE: To assess the efficacy, safety, and tolerability of a unique tazarotene 0.045% lotion formulation based on polymeric emulsion technology in subjects with moderate or severe acne. Methods: A total of 1614 subjects, 9 years and older were randomized to receive tazarotene 0.045% lotion or vehicle in two identical double-blind, randomized, vehicle-controlled 12-week studies evaluating safety and efficacy (inflammatory [papules and pustules] and noninflammatory [comedonal] lesion counts and using Evaluator Global Severity Scores [EGSS]). Treatment success was defined as at least a 2-grade improvement in EGSS and ‘clear’/’almost clear’ and efficacy assessed through reduction in lesion counts. In addition, patients completed a validated Acne-Specific Quality of Life (Acne-QoL) questionnaire. Safety, adverse events (AEs), and cutaneous tolerability were assessed throughout. RESULTS: Tazarotene 0.045% lotion demonstrated statistically significant superiority to vehicle in reducing inflammatory and noninflammatory lesion counts at week 12. Mean percent reductions in inflammatory and noninflammatory lesions were 55.5% and 51.4% (Study 1, both P<0.001 versus vehicle [45.7% and 41.5%, respectively]) and 59.5% and 60.0% (Study 2, both P<0.001 versus vehicle [49.0% and 41.6%, respectively]), with tazarotene 0.045% lotion at week 12. Treatment success was achieved by 25.5% (Study 1) and 29.6% (Study 2) of subjects treated with tazarotene 0.045% lotion (both P<0.001 versus vehicle [13.0% and 17.3%, respectively]). Improvements in QoL domain scores were consistently greater with tazarotene. Tazarotene 0.045% lotion was well-tolerated. The most common treatment-related AEs were application site pain (5.3%), dryness (3.6%), and exfoliation (2.1%). CONCLUSION: Tazarotene 0.045% lotion provides statistically significant greater efficacy than vehicle in terms of lesion reduction and treatment success, with a highly favorable safety and tolerability profile in moderate-to-severe acne patients. JJ Drugs Dermatol. 2020;19(1):70-77. doi:10.36849/JDD.2020.3977
他扎罗汀已在临床试验中得到广泛研究，并被广泛用于治疗寻常痤疮，数据表明它是最有效的外用维甲酸之一。乳膏、泡沫和凝胶制剂引起的刺激限制了其在临床实践中的应用。目的：评估基于聚合物乳液技术的独特的0.045%他扎罗汀洗剂在中度或重度痤疮患者中的疗效、安全性和耐受性。方法：在两项相同的双盲、随机、赋形剂对照的12周研究中，共1614名9岁及以上的受试者被随机分配接受0.045%他扎罗汀洗剂或赋形剂，以评估安全性和疗效（炎症性[丘疹和脓疱]和非炎症性[粉刺]皮损计数，并使用评估者整体严重程度评分[EGSS]）。治疗成功定义为EGSS至少提高2级且“清除”/“几乎清除”，并通过皮损计数减少来评估疗效。此外，患者完成了一份经过验证的痤疮特异性生活质量（Acne-QoL）问卷。全程评估安全性、不良事件（AE）和皮肤耐受性。结果：在第12周时，0.045%他扎罗汀洗剂在减少炎症性和非炎症性皮损计数方面显示出统计学上显著优于赋形剂。炎症性和非炎症性皮损的平均减少百分比分别为55.5%和51.4%（研究1，与赋形剂相比，两者P<0.001[分别为45.7%和41.5%]）以及59.
