一种新型局部角质溶解疗法治疗成人局限性角化过度的疗效与安全性。

Sadick Neil S, Coutanceau Christine, Sibaud Vincent, Merial-Kieny Christelle

Sadick Dermatology, New York, NY, USA.

J Drugs Dermatol. 2010 Dec;9(12):1512-7.

BACKGROUND

Palmoplantar keratoderma (PPK) is a heterogeneous group of skin disorders characterized by symmetrical diffuse or patchy areas of hyperkeratosis on the palms and soles. This study aimed to evaluate the efficacy and safety of a topical keratolytic treatment for localized hyperkeratosis.

METHODS

International, randomized, vehicle-controlled, double-blind, intra-individual comparative study.

RESULTS

Clinical signs assessed by the investigator significantly improved in both group from baseline to day 10 and day 21 (P<0.001). Mean improvement was significantly more marked on the treated side than the control side (except pruritus) at day 10 for hyperkeratosis (-0.58 ± 0.59 versus -0.41 ± 0.51, P=0.009), desquamation (-0.62 ± 0.69 versus -0.47 ± 0.67, P=0.042) and dryness (-0.75 ± 0.67 versus -0.57 ± 0.67, P=0.014). At day 21, dryness (-1.16 ± 0.80 versus -1.00 ± 0.79, P=0.036) was significantly improved but only a trend for hyperkeratosis (-0.86 ± 0.76 versus -0.72 ± 0.72, P=0.158) and desquamation (-0.83 ± 0.85 versus -0.65 ± 0.85, P=0.057) was observed. Tolerance was considered to be good or very good in more than 92 percent patients. Both patients and investigators were satisfied in more than 84 percent of cases with the topical keratolytic treatment efficacy. Safety profile was highly satisfactory.

CONCLUSION

This topical keratolytic treatment represents a valuable first-line option for mild to moderate hyperkeratosis.

背景

掌跖角化病（PPK）是一组异质性皮肤疾病，其特征为手掌和足底出现对称性弥漫性或斑片状角化过度区域。本研究旨在评估一种局部角质溶解治疗对局限性角化过度的疗效和安全性。

方法

国际、随机、赋形剂对照、双盲、个体内比较研究。

结果

从基线到第10天和第21天，研究者评估的临床体征在两组中均有显著改善（P<0.001）。在第10天，治疗侧的平均改善在角化过度（-0.58±0.59对-0.41±0.51，P=0.009）、脱屑（-0.62±0.69对-0.47±0.67，P=0.042）和干燥（-0.75±0.67对-0.57±0.67，P=0.014）方面比对照侧更显著（瘙痒除外）。在第21天，干燥（-1.16±0.80对-1.00±0.79，P=0.036）有显著改善，但仅观察到角化过度（-0.86±0.76对-0.72±0.72，P=0.158）和脱屑（-0.83±0.85对-0.65±0.85，P=0.057）的改善趋势。超过92%的患者耐受性良好或非常好。超过84%的病例中患者和研究者对局部角质溶解治疗效果满意。安全性概况非常令人满意。