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首页> 外文期刊>The American journal of cosmetic surgery: journal of the American Society of Cosmetic Surgeons [and] official publication of the American Society of Lipo-Suction Surgery >The Safety and Efficacy of Botulinum Toxin Type A Plus Tazarotene 0.1% Cream in the Treatment of Lateral Canthal Rhytids: A Randomized, Double-Blind, Placebo-Controlled Study
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The Safety and Efficacy of Botulinum Toxin Type A Plus Tazarotene 0.1% Cream in the Treatment of Lateral Canthal Rhytids: A Randomized, Double-Blind, Placebo-Controlled Study

机译：A型肉毒杆菌毒素加他扎罗汀0.1％乳膏治疗外侧Can管的安全性和有效性：一项随机，双盲，安慰剂对照的研究

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Background: Prior studies have established that botulinum toxin type A (BTX-A) is a safe and effective treatment of coarse dynamic rhytids. However, BTX-A has little known effect on the mottled hyperpigmentation, tactile roughness, skin thinning, and fine wrinkles that develop on periorbital skin as a result of cumulative photodamage. In contrast, topical retinoids have demonstrated the capacity to reverse clinical signs of cumulative photodamage in a number of studies. We hypothesize that the combination of BTX-A plus a topical retinoid (tazarotene 0.1% cream) for the treatment of lateral canthal rhytids (crow's feet) may be synergistic.Objective: To evaluate the effect of tazarotene 0.1% cream on crow's feet and mottled hyperpigmentation after a single treatment with BTX-A.Methods: This is a 16-week, single-center, double-blind, randomized, placebo-controlled study comparing the safety and efficacy of a single 12-U bilateral injection of BTX-A (Botox, Allergan Inc, Irvine, Calif) into the lateral third of the orbicularis oculi muscle at day 0 followed by nightly application of tazarotene 0.1% cream (Avage, Allergan) to one side and placebo cream to the contralateral side. Lateral canthal rhytids and mottled hyperpigmentation were scored by blinded physician evaluators at baseline and monthly intervals based on physical examination of the subjects and high-quality digital photographs. Overall improvement and adverse side effects were rated by patients at each visit via a patient questionnaire.Results: Sixteen of 20 subjects (80%) completed the trial. The mean baseline wrinkle scores for the lateral canthal areas randomized to tazarotene or placebo cream were 3.53and 3.41, respectively (3 = moderate wrinkling). There were no statistically significant differences in the wrinkle scores between the two groups at baseline (P = .54). According to the blinded physician evaluators, the decreases from baseline of the mean wrinkle scores at the end of the trial (day 112) were 1.37 and 0.75 for the tazarotene-treated and the placebo-treated groups, respectively. There was 1.8-fold greater improvement from baseline of the mean wrinkle score of the tazarotene-treated group compared with placebo at the completion of the trial (P < .001). Treatment satisfaction scores assigned by the subjects were consistent with the physicians' evaluations. At the end of the trial (day 112), the subjects saw 2-fold greater improvement from baseline on the sides treated with tazarotene 0.1% cream versus those treated with placebo cream (P < .001). The mean mottled hyperpigmentation score for the sides randomized to tazarotene treatment improved 40%, from 4.07 (severe) at baseline to 2.4 (2 = mild, 3 = moderate) at the end of the trial (P < .001). Adverse side effects were few and transient and did not cause any subject to discontinue the study.Conclusion: Our results suggest that the therapeutic combination of BTX-A plus topical tazarotene 0.1% cream is a safe and more efficacious treatment of crow's feet and mottled hyperpigmentation than BTX-A treatment alone.
机译：背景：先前的研究已经确定，A型肉毒杆菌毒素（BTX-A）是安全有效的治疗粗大动荡的方法。但是，BTX-A对斑驳的色素沉着，触觉粗糙，皮肤变薄以及由于累积光损伤在眶周皮肤上形成的细皱纹几乎没有影响。相反，在许多研究中，局部类视黄醇显示出逆转累积光损伤临床迹象的能力。我们假设将BTX-A与局部类维生素A（他扎罗汀0.1％乳膏）联合用于治疗侧rh节（鱼尾纹）可能具有协同作用。方法：这是一项为期16周，单中心，双盲，随机，安慰剂对照的研究，比较了单次12U双侧BTX-A的安全性和有效性，为期16周。 （Botox，Allergan Inc，Irvine，CA）在第0天进入眼轮虫外侧外侧三分之一，然后每晚在一侧涂抹他扎罗汀0.1％乳膏（Avage，Allergan），在对侧涂抹安慰剂乳霜。盲人医师评估人员根据受试者的体格检查和高质量的数码照片，在基线和每月间隔对can侧丘脑节律和斑驳的色素沉着进行评分。每次访视时通过患者问卷对患者的总体改善和不良副作用进行评估。结果：20名受试者中有16名（80％）完成了试验。随机分为他扎罗汀或安慰剂乳膏的外侧can部平均基线皱纹评分分别为3.53和3.41（3 =中度皱纹）。基线时，两组之间的皱纹得分无统计学差异（P = 0.54）。根据盲法医师评估，在试验结束时（第112天），他扎罗汀治疗组和安慰剂治疗组的平均皱纹评分相对于基线的降低分别为1.37和0.75。在试验完成时，与安慰剂相比，他扎罗汀治疗组的平均皱纹评分较基线改善了1.8倍（P <.001）。由受试者分配的治疗满意度得分与医生的评估一致。在试验结束时（第112天），用他扎罗汀0.1％乳膏治疗的患者与安慰剂乳膏治疗的患者相比，基线改善了2倍（P <.001）。试验结束时，随机接受他扎罗汀治疗的一侧的平均斑驳色素沉着分数提高了40％，从基线的4.07（严重）提高到2.4（2 =轻度，3 =中度）（P <.001）。结论：我们的结果表明，BTX-A加局部他扎罗汀0.1％乳膏的治疗组合对鱼尾纹和斑驳的色素沉着是一种安全有效的治疗方法比单独使用BTX-A进行治疗。

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