Ferreira Cestari Tania, Hassun Karime, Sittart Alexandre, de Lourdes Viegas Maria
Department of Dermatology, Federal University of Rio Grande do Sul--Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil.
J Cosmet Dermatol. 2007 Mar;6(1):36-9. doi: 10.1111/j.1473-2165.2007.00288.x.
The aim of this study was to compare the efficacy and safety of a triple combination (TC) cream and monotherapy with hydroquinone (HQ) cream in the treatment of moderate to severe facial melasma. A total of 120 patients applied TC cream once daily or HQ cream twice daily for 8 weeks. Evaluations included static global severity assessment of melasma, improvement of melasma over time, local tolerability, and adverse events. TC cream was significantly more effective than HQ cream from week 4 onwards: lesions were approximately equivalent to the surrounding skin in 35% of all TC-treated patients, compared to 5% of those who used HQ cream (P = 0.0001). Improvement of more than 75% was achieved by 73% of TC cream patients and 49% of HQ cream patients (P = 0.007). The incidence of adverse events (erythema, burning sensation, and desquamation) was similar in both groups. No patient dropped out of the study because of drug-related adverse events. TC cream was more effective than the HQ cream for the treatment of moderate to severe facial melasma. Both products had similar safety profiles.
本研究旨在比较三联组合（TC）乳膏与氢醌（HQ）乳膏单药治疗中重度面部黄褐斑的疗效和安全性。总共120例患者每天一次涂抹TC乳膏或每天两次涂抹HQ乳膏，持续8周。评估内容包括黄褐斑的静态整体严重程度评估、黄褐斑随时间的改善情况、局部耐受性和不良事件。从第4周起，TC乳膏比HQ乳膏显著更有效：在所有接受TC治疗的患者中，35%的患者皮损与周围皮肤大致相同，而使用HQ乳膏的患者中这一比例为5%（P = 0.0001）。73%使用TC乳膏的患者和49%使用HQ乳膏的患者改善超过75%（P = 0.007）。两组不良事件（红斑、烧灼感和脱屑）的发生率相似。没有患者因药物相关不良事件退出研究。TC乳膏治疗中重度面部黄褐斑比HQ乳膏更有效。两种产品的安全性概况相似。
