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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

Pannucci, Christopher J. M.D., M.S.; Reavey, Patrick L. M.D., M.S.; Kaweski, Susan M.D.; Hamill, Jennifer B. M.P.H.; Hume, Keith M. M.A.; Wilkins, Edwin G. M.D., M.S.; Pusic, Andrea L. M.D., M.H.S.

Plastic and Reconstructive Surgery: March 2011 - Volume 127 - Issue 3 - p 1334-1342
doi: 10.1097/PRS.0b013e318204361d
Cosmetic: Original Articles
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Discussion

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.

Ann Arbor, Mich.; New York, N.Y.; La Mesa, Calif.; Shohola, Pa.; and Arlington Heights, Ill.

From the University of Michigan, Columbia University Medical Center, the Aesthetic Arts Institute of Plastic Surgery, JBH Consulting, the American Society of Plastic Surgeons, and Memorial Sloan-Kettering Cancer Center.

Received for publication June 3, 2010; accepted September 20, 2010.

Disclosure:Dr. Pannucci receives salary support from the National Institutes of Health T32 grant program (T32 GM-08616). None of the authors has a financial interest in any of the products, devices, or drugs mentioned in this article. This project was funded by an unrestricted grant from Obagi Medical Products to the Plastic Surgery Educational Foundation. Obagi Medical Products was not involved in any aspect of study design, data collection, or data analysis and has not previously reviewed or edited this article.

Christopher J. Pannucci, M.D., M.S.; Section of Plastic Surgery; Department of Surgery; 2130 Taubman Center, Box 0340; 1500 East Medical Center Drive; Ann Arbor, Mich. 48109; cpannucc@umich.edu

©2011American Society of Plastic Surgeons