A Randomized Controlled Trial of Skin Care Protocols for Facial Resurfacing: Lessons Learned from the Plastic Surgery Educational Foundation's Skin Products Assessment Research Study.

摘要

BACKGROUND: : The Skin Products Assessment Research Committee was created by the Plastic Surgery Educational Foundation in 2006. The Skin Products Assessment Research study aims were to (1) develop an infrastructure for Plastic Surgery Educational Foundation-conducted, industry-sponsored research in facial aesthetic surgery and (2) test the research process by comparing outcomes of the Obagi Nu-Derm System versus conventional therapy as treatment adjuncts for facial resurfacing procedures. METHODS: : The Skin Products Assessment Research study was designed as a multicenter, double-blind, randomized, controlled trial. The study was conducted in women with Fitzpatrick type I to IV skin, moderate to severe facial photodamage, and periocular and/or perioral fine wrinkles. Patients underwent chemical peel or laser facial resurfacing and were randomized to the Obagi Nu-Derm System or a standard care regimen. The study endpoints were time to reepithelialization, erythema, and pigmentation changes. RESULTS: : Fifty-six women were enrolled and 82 percent were followed beyond reepithelialization. There were no significant differences in mean time to reepithelialization between Obagi Nu-Derm System and control groups. The Obagi Nu-Derm System group had a significantly higher median erythema score on the day of surgery (after 4 weeks of product use) that did not persist after surgery. Test-retest photographic evaluations demonstrated that both interrater and intrarater reliability were adequate for primary study outcomes. CONCLUSIONS: : The authors demonstrated no significant difference in time to reepithelialization between patients who used the Obagi Nu-Derm System or a standard care regimen as an adjunct to facial resurfacing procedures. The Skin Products Assessment Research team has also provided a discussion of future challenges for Plastic Surgery Educational Foundation-sponsored clinical research for readers of this article.