背景:氯倍他索在短时间内治疗黄褐斑方面取得了显着效果;然而,由于存在局部副作用的风险,其使用受到限制。迄今为止,目前尚无序贯氯倍他索/对苯二酚治疗黄褐斑的对照试验。本研究旨在研究与分离使用4%氢醌(HQ)相比,0.05%氯倍他索随后4%氢醌(CLOB-HQ)的耐受性和功效。
方法:双盲,我们进行了50名面部黄褐斑患者的随机临床试验.他们被指示每晚服用0.05%的氯倍他索,持续14天,随后是4%氢醌46天(CLOB-HQ组),或使用氢醌60天(HQ组)。在纳入时进行了评估,治疗14天和60天后,测量改良黄褐斑面积和严重程度指数(mMASI),黄褐斑生活质量量表(MELASQoL),和比色法。全球美学改善量表(GAIS)由盲态评估者进行评估。
结果:在D14和D60的主要结果没有差异(P>0.1)。对于CLOB-HQ,在D14和D60时,mMASI的平均(CI95%)降低为13.2%(5.1-21.3%)和43.1%(32.2-54.0%),对于总部,分别为10.6%(5.9-27.5%)和44.8%(33.2-52.3%)。MELASQoL,比色光度,尽管两组之间没有差异,但GAIS均显示出逐步改善。没有发现严重的副作用。无毛细血管扩张病例,萎缩,或口周皮炎与CLOB的使用有关。
结论:序贯CLOB-HQ方案安全且耐受性良好,即使其疗效在治疗14或60天后与HQ没有差异。基于这些发现,在对苯二酚治疗黄褐斑前14天使用氯倍他索是不可取的。
BACKGROUND: Clobetasol has demonstrated remarkable results in treating melasma within a short time frame; however, its use is limited because of the risk of local side effects. To date, there is no controlled
trial on sequential clobetasol/hydroquinone for melasma. This
study aimed to investigate the tolerability and efficacy of 0.05% clobetasol followed by 4% hydroquinone (CLOB-HQ) in comparison to the isolated use of 4% hydroquinone (HQ).
METHODS: A double-blinded, randomized clinical
trial involving 50 women with facial melasma was performed. They were directed to apply 0.05% clobetasol every night for 14 days, followed by 4% hydroquinone for 46 days (CLOB-HQ group), or the use of hydroquinone for 60 days (HQ group). Evaluations were carried out at inclusion, and after 14 and 60 days of treatment, measuring modified Melasma Area and Severity Index (mMASI), Melasma Quality of Life scale (MELASQoL), and colorimetry. The Global Aesthetic Improvement Scale (GAIS) was assessed by a blinded evaluator.
RESULTS: There was no difference in the main outcomes at D14 and D60 (P > 0.1). For CLOB-HQ, the mean (CI 95%) reduction in mMASI was 13.2% (5.1-21.3%) and 43.1% (32.2-54.0%) at D14 and D60, and for HQ, they were 10.6% (5.9-27.5%) and 44.8% (33.2-52.3%). The MELASQoL, colorimetric luminosity, and GAIS showed a progressive improvement for both groups despite no difference between them. No severe side effects were identified. No cases of telangiectasias, atrophy, or perioral dermatitis were associated with the use of CLOB.
CONCLUSIONS: The sequential CLOB-HQ regimen was safe and well tolerated, even though its efficacy was not different from HQ after 14 or 60 days of treatment. Based on these findings, the use of clobetasol 14 days before hydroquinone is not advisable for the treatment of melasma.