【 文献重点摘要 】

Background

The Skin Products Assessment Research (SPAR) Committee was created by the Plastic Surgery Educational Foundation (PSEF) in 2006. SPAR study aims were to (1) develop an infrastructure for PSEF-conducted, industry sponsored research in facial aesthetic surgery and (2) test the research process by comparing outcomes of the Obagi Nu-Derm System (ONDS) versus conventional therapy as treatment adjuncts for facial resurfacing procedures.

Methods

The SPAR study was designed as a multi-center, double-blind, randomized controlled trial (RCT). The study was conducted in women with Fitzpatrick type I-IV skin, moderate to severe facial photo damage, and peri-ocular and/or peri-oral fine wrinkles. Patients underwent chemical peel or laser facial resurfacing and were randomized to ONDS or a standard care regimen. The study endpoints were time to re-epithelization, erythema, and pigmentation changes.

Results

Fifty-six women were enrolled and 82% were followed beyond re-epithelization. There were no significant differences in mean time to re-epithelialization between ONDS and control groups. The ONDS group had a significantly higher median erythema score on day of surgery (after 4 weeks of product use) which did not persist after surgery. Test-retest photo evaluations demonstrated that both inter- and intra-rater reliability were adequate for primary study outcomes.

Conclusions

In a clinical RCT, we demonstrated no significant difference in time to reepithelization between patients who used the ONDS or a standard care regimen as an adjunct to facial resurfacing procedures. The SPAR research team has also provided a discussion of future challenges for PSEF sponsored clinical research for readers of this article.

背景

皮肤产品评估研究委员会(SPAR)是由整形外科教育基金会(PSEF)于2006年创建的。SPAR研究的目的是(1)为PSEF进行的、由行业赞助的面部美容手术研究建立基础设施，(2)通过比较Obagi Nu-Derm系统(ODES)与作为面部表面重塑程序治疗辅助设备的传统疗法的结果来测试研究过程。

方法

SPAR研究采用多中心、双盲、随机对照试验(RCT)。这项研究是在Fitzpatrick I-IV型皮肤，中度到重度面部照片损伤，以及眼周和/或口腔周围细小皱纹的女性中进行的。患者接受化学剥离或激光面部重塑，并被随机分成DES或标准护理方案。研究终点是重新上皮化、红斑和色素改变的时间。

结果

56名女性入选，82%的患者在再次上皮化后获得随访。在平均再上皮化时间上，DES组和对照组之间没有显著差异。DES组在手术当天(使用产品4周后)的平均红斑评分显着较高，但在手术后并不持续。重测照片评估表明，评分者之间和评分者内部的可靠性都足以反映主要的研究结果。

结论

在一项临床随机对照试验中，我们显示使用DES或标准护理方案作为面部表面重塑程序的辅助手段的患者在再上皮化时间上没有显著差异。SPAR研究小组还为本文的读者讨论了PSEF赞助的临床研究的未来挑战。