Comparison of Calcipotriene (Dovonex®) With a Coal Tar Emulsion (Exorex®) in Treating Psoriasis in Adults: A Pilot Study
Authors and Description
Veronikis, I.E, Malabanan, A.O, Holick, M.F. A preliminary study comparing calcipotriol (Dovonex®) and coal tar emulsion (Exorex®) in the treatment of psoriasis in adults. Arch Dermatol.1999; 135: 474-475.
Abstract
Coal tar, a mixture of at least 10,000 components, has long been shown to have efficacy in the treatment of psoriasis.1 Exorex® (IMX Pharmaceuticals Inc, Boca Raton, Fla) is a new coal tar-based, Food and Drug Administration-sanctioned psoriasis medication deemed safe for sensitive skin. Calcipotriene (Dovonex®; Westwood-Squibb Pharmaceuticals, Buffalo, NY) is an active cholecalciferol analog, useful in psoriasis therapy, but which can cause dermatitis in sensitive areas.2 We conducted a pilot study comparing the therapeutic efficacy and safety of Dovonex® (hereinafter, “calcipotriene”) and Exorex® (hereinafter, “1% coal tar emulsion”) in treating psoriasis.
Patients and Methods
Twenty adult patients with plaque-type psoriasis (16 men and 4 women, aged 18-75 years) were enrolled in this single-blind intrapatient comparison study. Five dropped out after baseline evaluation. Each patient underwent a blood chemistry analysis, a complete blood cell count, and urinalysis at baseline and monthly through the study’s duration. Two similar 50-cm2 psoriatic lesions were selected in each patient for twice-daily treatment with either 0.1 g of calcipotriene or 0.1 g of the 1% coal tar emulsion followed 2 minutes later by application of moisturizing cream (Exorex® Stabilizing Cream; IMX Pharmaceuticals Inc). All treated lesions were photographed at baseline and at every visit. Erythema, scaling, and plaque thickness of the treated lesions were evaluated using a 4-point scale (0, no lesion; 2, mild; 4, moderate; 6, severe). After 2 months, 4-mm punch biopsy specimens were taken of the lesions treated with calcipotriene, those treated with the 1% coal tar emulsion, and normal skin.The patients were treated for a mean ( SD) 64.47.92 days (range, 12-125 days). Statistical significance was assessed by the 2-tailed Student t test for paired differences.
Results
The mean SD pretreatment severity scores for erythema, scaling, and plaque thickness were 4.1 0.3, 4.1 0.4, and 3.7 0.4, respectively. After treatment with the 1% coal tar emulsion, the scores for erythema, scaling, and plaque thickness decreased to 2.2 0.3 (a 41% 8% decrease; P<.001), 1.9 0.5 (a 56% 10% decrease; P<.01), and 2.4 0.4 (a 31% 13% decrease; P<.05), respectively. After treatment with calcipotriene, scores for erythema, scaling, and plaque thickness decreased to 2.1 0.2 (a 42% 8% decrease; P<.001), 1.6 0.4 (a 63% 9% decrease; P<.001), and 1.7 0.3 (a 47% 9% decrease; P<.001). No significant intertreatment difference was observed in improvement of scaling, erythema, or plaque elevation. No adverse effects or laboratory abnormalities were noted after treatment with either medication.
Comment
This pilot study suggests that this preparation of 1% coal tar emulsion is about as effective as calcipotriene in treating psoriasis. In this study, which was not vehicle controlled, the clinical improvement with either medication was comparable and substantial after 1 month of treatment. Long-term effects of 1% coal tar emulsion are not yet known, and further studies are indicated.
Irini E. Veronikis, MD
Alan O. Malabanan, MD
Michael F. Holick, PhD, MD
Department of Medicine
Boston University School of Medicine
715 Albany St, M-1013
Boston, Mass 02118
References
1. Silverman A, Menter A, Hairston JL. Tars and anthralins. Dermatol Clin. 1995;13:817-833. MEDLINE
2. Kragballe K. Treatment of psoriasis by the topical application of the novel cholecalciferol analogue calcipotriol. Arch Dermatol. 1989;125:1647-1652. MEDLINE
3. British Journal of Dermatology. Volume 149 (2003), pages 350-353.
Supported in part by grant M01RR00533 from the National Institutes of Health, Bethesda, Md, and funding from IMX Pharmaceuticals Inc, Boca Raton, Fla.
Presented in part at the 58th Annual Meeting of the Society for Investigative Dermatology, Washington, DC, April 26, 1997.
临床研究Exorex与Dovonex 对照
观察者都不知道分组情况，随机的，比较一种新型的1％煤焦油制剂（Exorex®）和钙泊三醇霜（Dovonex®）对斑块型牛皮癣治疗。
作者：S. Tzaneva，H. Hönigsmann，A. Tanew。
特殊环境皮肤科，皮肤科，
维也纳医学院，奥地利大学。
总结
在最近的一项试验研究了一种新的，专利的基础脂肪酸， 1％的煤焦油制剂（Exorex®）
已被发现在治疗牛皮癣的效果和钙泊三醇霜有一样有效。
目标
我们的目的是探讨新的疗效，安全性和可接受性的化妆品,
1％煤焦油制剂Exorex®，以较多的病人与钙泊三醇霜进行比较。
患者和方法
40位慢性斑块型牛皮癣患者被列入这项随机，观察者都不知道分组情况。
比较试验，在每一个病人两个可比较的目标斑块处理二次,每日用1％煤焦油制剂或钙泊三醇霜。在治疗的开始，并在第2，4，
6和8周，对治疗的反应的牛皮癣的严重程度指数（PSI），红斑程度，浸润和牛皮癣皮受损的大小, 以五点量表进行程度测定。
此外，还记录了所有的治疗相关的副作用和两者的化妆品可接受性
治疗是每第二个星期由病患进行评等。在完全或接近完全清除后，病患会被追踪一直到有复发或是18个月的最长期限。
结果
38例患者完成了这项研究。在试用结果的平均值±SD基准的PSI，
试用煤焦油渗透乳液，原来9·2±1·5减少至3·0±2·9，试用钙泊三醇霜减少至2·8±2·7。
基线和最终的评估之间的平均PSI减少，1％煤焦油渗透乳液和钙泊三醇霜（P = 0·77）之间没有显著差异。在减少1％的煤焦油渗透乳液和钙泊三醇霜之间PSI评分的平均个体内差异为0·1的得分点（95％置信区间-0·84 + 0·63）。观察相对于时间，直到复发之间没有任何区别。瘙痒感有4个患者是用1％的煤焦油渗透乳液引起, 一个患者是用钙泊三醇霜引起的。六名患者指出1％煤焦油渗透乳液有不愉快的气味, 或在1％的煤焦油制剂染，而一患者抱怨钙泊三醇霜的气味。
结论
新式的1％的煤焦油乳液被认为是和钙泊三醇霜, 对治疗牛皮癣一样有效。耐受性和化妆品可接受性比钙泊三醇霜更好。考虑到煤焦油渗透乳比钙泊三醇霜便宜，这个新产品显示对慢性斑块型牛皮癣是一个非常有用的局部用药。
参考
Valk, P.G.M. van der, E. Snater, Verbeek-Gijsbers, P. Duller, P.C.M. van der Kerkhof.。
我的过敏性皮炎病人用煤焦油乳液治疗。皮肤科96; 193：41-44。
Veronikis，即Malaban，A.O.，Holick，M.F。钙泊三醇（Dovonex）与
煤焦油乳液（Exorex）治疗牛皮癣成人的初步研究比较。Arch Dermato。
1999年; 135：474-475。
资料来源：英国皮肤病学杂志。 149卷（2003），页350-353。
