Lowe N J, Rizk D, Grimes P, Billips M, Pincus S
Clinical Research Specialists, Santa Monica, California, USA.
Clin Ther. 1998 Sep-Oct;20(5):945-59. doi: 10.1016/s0149-2918(98)80076-3.
This multicenter, randomized, double-masked, parallel-group study assessed the efficacy, safety, and tolerability of azelaic acid 20% cream compared with those of its vehicle for the treatment of facial hyperpigmentation in darker-skinned patients (phototypes IV to VI). Following a 24-week treatment period, azelaic acid produced significantly greater decreases in pigmentary intensity than did vehicle as measured by both an investigator's subjective scale (P = 0.021) and a chromometer analysis (P = 0.039). There was a significantly greater global improvement with azelaic acid than with vehicle at week 24 (P = 0.008). Azelaic acid produced a slightly but significantly greater amount of burning (weeks 4 and 12, P < or = 0.046) and stinging (week 4, P = 0.002) than did vehicle. At the end of the study, more patients treated with azelaic acid than with vehicle reported having much smoother skin and being very satisfied or satisfied with their treatment. Also, more patients treated with azelaic acid than with vehicle rated their medication as being more effective or the same as past treatments. Thus azelaic acid is an effective and well-tolerated treatment for hyperpigmentation in darker-skinned patients.
这项多中心、随机、双盲、平行组研究评估了20%壬二酸乳膏与其赋形剂相比，治疗深色皮肤患者（IV至VI型光皮肤型）面部色素沉着的疗效、安全性和耐受性。在24周的治疗期后，通过研究者主观评分（P = 0.021）和色差计分析（P = 0.039）测量，壬二酸导致的色素沉着强度下降显著大于赋形剂。在第24周时，壬二酸在整体改善方面显著优于赋形剂（P = 0.008）。与赋形剂相比，壬二酸产生的灼烧感（第4周和第12周，P≤0.046）和刺痛感（第4周，P = 0.002）略多但显著。在研究结束时，与赋形剂治疗的患者相比，更多接受壬二酸治疗的患者报告皮肤更光滑，对治疗非常满意或满意。此外，与赋形剂治疗的患者相比，更多接受壬二酸治疗的患者将他们的药物评为比过去的治疗更有效或相同。因此，壬二酸是治疗深色皮肤患者色素沉着的一种有效且耐受性良好的疗法。
