This study was not powered to reach statistical significance, and although it did not, almost
twice as many subjects in the combined treatment arms reported subjective improvements (73%) when compared with the placebo arm (38%). The observed effect could result from a treatment effect of the vehicle itself, but these results suggest that topical application of our study product is effective in improving the appearance of facial angiofibromas in people with TSC. Future studies will include more detailed monitoring of efficacy, including standardized photography and monthly quality-of-life questionnaires. Acknowledgments This study was supported in part by the Society for Pediatric Dermatology, Cheniere Energy, Inc., the Sponsors of Kirk and Meg Gentle of the Cheniere Race Across
America Team, the University of Texas Medical School at Houston Department Crenolanib mouse of Pediatrics, Selleck Gefitinib and the University of Texas Tuberous Sclerosis Center of Excellence at the University of Texas Medical School at Houston. The sponsors had no role in the design and conduct of the study; in the collection, analysis, or interpretation of data; or in the preparation, review, or approval of the manuscript. The authors have no relevant financial or conflicts of interest to disclose. We are indebted to Dr. Laura Lester and Dr. Laura Marusinec for their assistance in this clinical trial. We thank Biomedical Development Corporation for their role in the production of the topical study product. References 1. Schwartz RA, Fernandez G, Kotulska K, et al. Tuberous sclerosis complex: advances in diagnosis, genetics, and management. J Am Acad Dermatol 2007; 57: 189–202.CrossRefPubMed 2. Kane Y. The “bumps” on my face. J Am Acad Dermatol 2004; 51: S11–2CrossRefPubMed 3. El-Musa KA, Shehadi RS, Shehadi S. Extensive facial adenoma
sebaceum: successful treatment with mechanical dermabrasion: case report. Brit J Plast Surg 2005; 58: 1143–7.CrossRefPubMed 4. Finch TM, Hindson C, Cotterill JA. Successful treatment of adenoma sebaceum with the potassium titanyl phosphate laser. Clin Exp Dermatol 1998; 23: 201–3.CrossRefPubMed 5. Hori K, Soejima K, Nozaki M, Sinomenine et al. Treatment of facial angiofibromas of tuberous sclerosis using cultured epithelial autografts. Ann Plast Surg 2006; 57: 415–7.CrossRefPubMed 6. Kaufman AJ, Grekin RC, Geisse JK, et al. Treatment of adenoma sebaceum with the copper vapor laser. J Am Acad Dermatol 1995; 33: 770–4.CrossRefPubMed 7. Papadavid E, Markey A, Bellaney G, et al. Carbon dioxide and pulsed dye laser treatment of angiofibromas in 29 patients with tuberous sclerosis. Brit J Plast Surg 2002; 147: 337–42. 8. Verheyden CN. Treatment of the facial angiofibromas of tuberous sclerosis. Plast Reconstr Surg 1996; 98: 777–83.CrossRefPubMed 9. Bittencourt RC, Huilgol SC, Seed PT, et al. Treatment of angiofibromas with scanning carbon dioxide laser: a clinicopathologic study with long-term follow-up.