Purpose: This prospective randomized, double-blinded study is designed to evaluate the effectiveness of ALA on the lip scars of infants with cleft lips undergoing primary cheiloplasty.

Methods: 62 patients underwent primary cheiloplasty at the same institution from July 1, 1998 to June 30, 1999. 20 patients were randomly assigned to the study protocol. Patient's families were informed and consent obtained. A modified rotation advancement procedure with primary cleft nasal reconstruction was performed. Sutures were removed at day 6. At day 14 the families were instructed to begin lip scar taping and massage daily for 10 minutes, 3 times each day for 3 months. Monthly follow-up was obtained to assess patient and family compliance. Lip massage cream was provided by N.V. Perricone, MD Cosmeceuticals and each bottle was coded by the factory scientist. The active ingredient in the massage cream was alpha lipoic acid. The control bottles contained the same product without the ALA. Scar analysis was performed at 1 year using the quantitative scale developed by Beausang et.al (PRS, Vol. 102 No. 6, Nov. 1998)

Results: 6 patients were disqualified due to inadherence to the study protocol or refusal to return for follow-up photographs. (Many patients live greater than 250 miles from the center) 14 patient scars who satisfied the criteria were evaluated. 7 patients were in the placebo and 7 were in the active groups, once the key was obtained from the factory. Mean score in the placebo group was 13.18 and in the active group 8.12. Standard deviations were 3.13 and 2.52 respectively. Using paired T-Test analysis, the scores in the active group were statistically significant for improved scars with p=0.05.

Conclusion: Adding ALA along with our standard post-op scar taping and massage resulted in improved lip scars in patients undergoing primary cheiloplasty. A larger study will be helpful in detecting the greatest benefit of this antioxidant therapy.