Anadolu R Y, Sen T, Tarimci N, Birol A, Erdem C
Ankara University Faculty of Medicine, Department of Dermatology, Ankara, Turkey.
J Eur Acad Dermatol Venereol. 2004 Jul;18(4):416-21. doi: 10.1111/j.1468-3083.2004.00929.x.
Retinoic acid (RA) has long been used, both topically and systemically, for disorders of keratinization, acne and related disorders. In the present study, the efficacy and tolerability of topical RA prepared as a cyclodextrin beta complex (beta-CD) is investigated in 66 acne vulgaris patients.
This randomized, double-blind, placebo-controlled study compares nightly topical application of RA/beta-CD complex hydrogel formulation (0.025%), RA/beta-CD complex in moisturizing base (0.025%), hydrogel base, moisturizer base or a commercial RA gel (0.05%) in acne vulgaris patients. Improvement of acne was assessed using a 5-point improvement scale and by measuring sebum and moisture content of the skin using an SM 810 sebumeter/corneometer.
After 3 months of treatment, mean scores of acne improvement on the 5-point scale were 4 with the RA/beta-CD complex hydrogel formulation, 4.1 with the RA/beta-CD complex in moisturizing base, 1.2 with hydrogel placebo base, 1.1 with moisturizer placebo base and 3 with the commercial RA product. All patients treated with the commercial product experienced local side-effects. One patient discontinued due to severe irritation. None of the patients treated with the RA/beta-CD complex in the moisturizing base and hydrogel formulation experienced significant local irritation, although the sebum content of the skin decreased after application of the RA/beta-CD preparations. This change was not significant compared to controls. The moisture content of the skin was better preserved in the group treated with the RA/beta-CD complex in the moisturizing base.
The topical RA/beta-CD complex, in hydrogel and moisturizing base, was more effective than the twice concentrated commercial RA product. There were few topical side-effects with this new formulation, which increases patient compliance. Topical RA/beta-CD (0.025% RA) did not significantly reduce sebum secretion but may help to preserve optimum epidermal moisture content with the proper base formulation. This is the first study in the literature reporting efficacy and tolerability of the topical RA/beta-CD complex in acne vulgaris. We conclude that the topical RA/beta-CD complex displays an improved efficacy and tolerability profile and is an effective treatment alternative for acne vulgaris.
维甲酸（RA）长期以来一直局部和全身用于治疗角化异常、痤疮及相关疾病。在本研究中，对66例寻常痤疮患者研究了作为环糊精β复合物（β-CD）制备的局部RA的疗效和耐受性。
这项随机、双盲、安慰剂对照研究比较了寻常痤疮患者每晚局部应用RA/β-CD复合水凝胶制剂（0.025%）、保湿基质中的RA/β-CD复合物（0.025%）、水凝胶基质、保湿基质或市售RA凝胶（0.05%）的情况。使用5分改善量表评估痤疮的改善情况，并使用SM 810皮脂仪/角质层水合测定仪测量皮肤的皮脂和水分含量。
治疗3个月后，5分量表上痤疮改善的平均得分，RA/β-CD复合水凝胶制剂为4分，保湿基质中的RA/β-CD复合物为4.1分，水凝胶安慰剂基质为1.2分，保湿剂安慰剂基质为1.1分，市售RA产品为3分。所有使用市售产品治疗的患者均出现局部副作用。1例患者因严重刺激而停药。在保湿基质和水凝胶制剂中使用RA/β-CD复合物治疗的患者均未出现明显的局部刺激，尽管应用RA/β-CD制剂后皮肤的皮脂含量有所下降。与对照组相比，这种变化并不显著。在保湿基质中使用RA/β-CD复合物治疗的组中，皮肤的水分含量得到了更好的保持。
水凝胶和保湿基质中的局部RA/β-CD复合物比市售的两倍浓度RA产品更有效。这种新制剂几乎没有局部副作用，这提高了患者的依从性。局部RA/β-CD（0.025% RA）并没有显著减少皮脂分泌，但在适当的基质配方下可能有助于保持最佳的表皮水分含量。这是文献中第一项报道局部RA/β-CD复合物治疗寻常痤疮的疗效和耐受性的研究。我们得出结论，局部RA/β-CD复合物显示出更好的疗效和耐受性，是寻常痤疮的一种有效治疗选择。
