Maloney J M, Morman M R, Stewart D M, Tharp M D, Brown J J, Rajagopalan R
Cherry Creek Dermatology, Denver, Colorado, USA.
Int J Dermatol. 1998 Feb;37(2):142-4. doi: 10.1046/j.1365-4362.1998.00394.x.
A 4-week, double-blind, randomized clinical trial, comparing the efficacy and safety of clobetasol propionate emollient cream 0.05% and its vehicle, was conducted at four private dermatology clinics in 81 non-hospitalized patients (> or = 12 years old) with moderate-to-severe atopic dermatitis covering 2% or more of their body surface. All patients had at least one lesion 2 cm or more in diameter. Three signs/symptoms of target lesions (erythema, pruritus, and induration/papulation) were scored by investigators on a scale of 0-3 (in 0.5-point increments; 0 = absent, 1 = mild, 2 = moderate, and 3 = severe); the total of the three scores had to be > or = 6 for patients to qualify for study entry. Patients were excluded if they were immunocompromised, pregnant, or nursing; had skin atrophy, telangiectasia or striae in skin areas to be treated; or had received topical treatments for atopic dermatitis within 1 week prestudy, intramuscular triamcinolone within 6 weeks prestudy, or long-term systemic corticosteroid usage within 6 months prestudy. Patients were randomized in a 1:1 ratio to receive either clobetasol propionate emollient 0.05% twice daily (n = 41), or the emollient vehicle twice daily (n = 40), for 4 weeks. A fingertip unit, equaling approximately 0.5 g in males and 0.43 g in females (enough to cover approximately 2% of the body), was used to measure and apply a thin film of study drug to the affected areas. The efficacy was evaluated by investigators and patients on days 4, 8, 15, and 29 after initiation of therapy, and 2 weeks after the end of treatment (day 43). Investigators performed a physician's gross assessment based on the percentage improvement of the target lesion. They also rated changes from baseline in mean severity scores for six individual signs/symptoms (erythema, pruritus, induration/papulation, lichenification, erosion/oozing/crusting, and scaling/dryness) and for total signs/symptoms according to the severity scoring system described above. Patients rated their response to treatment as excellent, good, fair, poor, or worse. Laboratory assessments were made on days 15, 29, and (if necessary) day 43.
在四家私立皮肤科诊所对81名非住院患者（年龄≥12岁）进行了一项为期4周的双盲随机临床试验，比较0.05%丙酸氯倍他索润肤霜及其赋形剂的疗效和安全性，这些患者患有中度至重度特应性皮炎，皮损面积覆盖身体表面积的2%或更多。所有患者至少有一个直径2厘米或更大的皮损。研究人员对目标皮损的三个体征/症状（红斑、瘙痒和硬结/丘疹）按0 - 3分进行评分（以0.5分为增量；0 = 无，1 = 轻度，2 = 中度，3 = 重度）；患者入选研究的条件是这三个评分的总和≥6分。如果患者存在免疫功能低下、怀孕或正在哺乳；待治疗皮肤区域有皮肤萎缩、毛细血管扩张或萎缩纹；或在研究前1周内接受过特应性皮炎的局部治疗、研究前6周内接受过肌内注射曲安奈德或研究前6个月内长期使用过全身性皮质类固醇，则将其排除。患者按1:1的比例随机分组，分别接受0.05%丙酸氯倍他索润肤霜每日两次（n = 41）或赋形剂每日两次（n = 40），持续4周。一个指尖单位，男性约为0.5克，女性约为0.43克（足以覆盖身体约2%的面积），用于测量并将一层薄的研究药物涂抹于患处。在治疗开始后的第4、8、15和29天以及治疗结束后2周（第43天），由研究人员和患者对疗效进行评估。研究人员根据目标皮损的改善百分比进行医生总体评估。他们还根据上述严重程度评分系统，对六个个体体征/症状（红斑、瘙痒、硬结/丘疹、苔藓化、糜烂/渗出/结痂和脱屑/干燥）以及总体体征/症状的平均严重程度评分相对于基线的变化进行评级。患者将他们对治疗的反应评为优秀、良好、中等、差或更差。在第15、29天以及（如有必要）第43天进行实验室评估。
