PDF(Pubmed)
Abstract：
Lichen planus is chronic inflammatory mucocutaneous disease. Involvement of nails (nail lichen planus: NLP) could be the only manifestation or it could be associated with the other typical skin and mucous localizations. Typical NLP alterations are linear nail bed dyschromia, longitudinal ridging, splitting, onycholysis, and subungual hyperkeratosis. Pterygium could be observed in advanced stages. Treatment of NLP is challenging. Limited clinical data have suggested that both oral and topical retinoids could be beneficial. Recently, a nail lacquer containing urea (20%), keratinase from Bacillus licheniformis, and hydroxipinacolone retinoate (U-KR lacquer) has been available. This product has shown good efficacy in the treatment of onychodystrophy characterized by onychogryphosis. We have evaluated, in a case series pilot study, the efficacy of this lacquer in subjects with moderate NLP. The product was applied once daily on the affected nails. Ten subjects (6 men and 4 women, mean age 38 years) after their written informed consent, with clinical NLP (2 subjects with histological confirmation) affecting foot or hand nails (mean number of nails involved: 4; range from 1 to 10), were treated for 12 consecutive weeks with U-KR, one application per day. The main endpoint was the evolution of a NLP severity score (NLPSS) evaluating 7 nail signs: grade of onycholysis, longitudinal ridging, splitting, grade of subungual hyperkeratosis, nail bed thickening, dyschromia, and nail pitting. For each item, a 4-grade score (from 0: no sign to 3: severe) was used (range of NLPSS from 0 to 21). At baseline, the NLPSS was 20.8 ± 3. After 12 weeks, the NLPSS showed a significant reduction to 4 ± 8.8, representing an 81% reduction in comparison with baseline value (p = 0.0001), with an absolute difference between means of -16.86 ± 2,586 (95% CI of the difference: from -22.49 to -11.22) The product was very well tolerated. This 10-case pilot study suggests that a nail lacquer with 3 components (urea, keratinase, and a retinoid molecule) could be useful in subjects with NLP. Future controlled trials are warranted to better define the therapeutic potential of this product in NLP treatment.
摘要：
扁平苔藓是慢性炎症性皮肤粘膜疾病。指甲（指甲扁平苔藓：NLP）的参与可能是唯一的表现，也可能与其他典型的皮肤和粘液局部化有关。典型的NLP改变是线性甲床色素异常，纵向起皱,分裂,甲状腺溶解症,和甲下角化过度症.在晚期可以观察到翼状胬肉。NLP的治疗具有挑战性。有限的临床数据表明，口服和局部类维生素A可能是有益的。最近,含尿素（20%）的指甲漆，来自地衣芽孢杆菌的角蛋白酶，和羟哌酮视黄酸（U-KR漆）已可用。该产品在治疗以甲后凸畸形为特征的甲营养不良中显示出良好的疗效。我们评估过,在一个案例系列试点研究中，这种漆在中度NLP受试者中的功效。将该产品每天施用一次在受影响的指甲上。10名受试者(6名男性和4名女性，平均年龄38岁)在他们书面知情同意后，临床NLP（2例组织学证实）影响脚或手指甲（平均涉及的指甲数量：4；范围从1到10），用U-KR连续治疗12周，每天一份申请。主要终点是评估7种指甲体征的NLP严重程度评分（NLPSS）的演变：纵向起皱,分裂,甲下角化过度程度,甲床增厚,色素异常,和指甲凹陷。对于每个项目，使用4级评分(从0:无体征到3:严重)(NLPSS的范围从0到21).在基线,NLPSS为20.8±3。12周后,NLPSS显示显着降低至4±8.8，与基线值相比降低了81％（p=0.0001），平均值之间的绝对差异为-16.86±2,586（差异的95％CI：从-22.49到-11.22）。这项10例试点研究表明，一种含有3种成分(尿素，角蛋白酶,和类维生素A分子）可用于NLP受试者。有必要进行未来的对照试验，以更好地定义该产品在NLP治疗中的治疗潜力。
