Del Rosso James Q, Kircik Leon
J Clin Aesthet Dermatol. 2012 Jul;5(7):20-4.
Clocortolone pivalate is a mid-potency topical corticosteroid available as a 0.1% emollient cream approved by the United States Food and Drug Aministration for use in the treatment of corticosteroid-responsive dermatoses. The vehicle is formulated for application to a variety of corticosteroid-responsive skin disorders, including those with inflamed and fissured skin, such as eczematous dermatoses. Hence, the potency of the formulation and its vehicle characteristics are important when treating disorders, such as atopic dermatitis and other eczematous dermatoses, which are prone to cutaneous irritation and skin sensitivity to exogenously applied agents. As both localized and diffuse eczematous dermatoses and seborrheic dermatitis are common in pediatric patients (including infants) as well as in adults, the fact that clocortolone pivalate 0.1% cream has no age restriction related to its use according to United States Food and Drug Aministration-approved product labeling is important to recognize. The chemical structure of clocortolone pivalate is a unique design that provides high lipid solubility. Highly lipophilic topical corticosteroids exhibit augmented penetration through the stratum corneum, which provides higher epidermal concentrations. It has been reported that the structural characteristics of this molecule enhance its potency without increasing the potential for topical corticosteroid-related adverse effects. Clocortolone pivalate 0.1% cream has been studied in randomized, controlled trials of patients with atopic dermatitis and other eczematous dermatoses, psoriasis vulgaris, contact dermatitis, and seborrheic dermatitis. It has been shown to be more effective as monotherapy in the treatment of these corticosteroid-responsive dermatoses than the vehicle. Its efficacy and safety in pediatric patients and patients with facial dermatoses have also been demonstrated. Patients using clocortolone pivalate 0.1% topical cream in clinical trials had a low rate of adverse events, which were primarily minor application-site reactions. Systemic reactions related to the drug were not observed in these trials. Clinical studies of patients with corticosteroid-responsive dermatological conditions have found that clocortolone pivalate 0.1% cream is an effective class 4 topical corticosteroid with a favorable safety profile.
戊酸氯倍他松是一种中效外用皮质类固醇，有0.1%的润肤乳膏剂型，已获美国食品药品监督管理局批准用于治疗对皮质类固醇有反应的皮肤病。该制剂适用于多种对皮质类固醇有反应的皮肤疾病，包括皮肤发炎和有裂痕的疾病，如湿疹性皮炎。因此，在治疗特应性皮炎和其他湿疹性皮炎等容易出现皮肤刺激和对外用药物皮肤敏感的疾病时，制剂的效力及其载体特性很重要。由于局限性和弥漫性湿疹性皮炎以及脂溢性皮炎在儿科患者（包括婴儿）和成人中都很常见，根据美国食品药品监督管理局批准的产品标签，0.1%戊酸氯倍他松乳膏在使用上没有年龄限制，这一点很重要。戊酸氯倍他松的化学结构是一种独特的设计，具有高脂质溶解度。高度亲脂性的外用皮质类固醇表现出增强的透过角质层的渗透能力，从而使表皮浓度更高。据报道，该分子的结构特征增强了其效力，同时又不会增加外用皮质类固醇相关不良反应的可能性。0.1%戊酸氯倍他松乳膏已在特应性皮炎和其他湿疹性皮炎、寻常型银屑病、接触性皮炎和脂溢性皮炎患者的随机对照试验中进行了研究。结果表明，作为单一疗法，它在治疗这些对皮质类固醇有反应的皮肤病方面比载体更有效。其在儿科患者和面部皮肤病患者中的疗效和安全性也得到了证实。在临床试验中使用0.1%戊酸氯倍他松外用乳膏的患者不良事件发生率较低，主要是轻微的用药部位反应。在这些试验中未观察到与该药物相关的全身反应。对皮质类固醇反应性皮肤病患者的临床研究发现，0.1%戊酸氯倍他松乳膏是一种有效的4类外用皮质类固醇，安全性良好。
