Our pilot study of botulinum toxin-A injected into painful skin leiomyomas will evaluate whether patients receive pain relief in the 12 weeks after injection. Given the often subjective nature of pain, we have designed the study in a placebo-controlled and double-blinded fashion. For the duration of the study, subjects will rate their pain using standardized pain scoring scales at study visits and through a pain diary. Subjects will also complete quality of life assessments. In FY 2011, we enrolled 1 new subject who received botulinum toxin-A or placebo and continued follow-up on previously enrolled subjects.
|Naik, Haley B; Steinberg, Seth M; Middelton, Lindsay A et al. (2015) Efficacy of Intralesional Botulinum Toxin A for Treatment of Painful Cutaneous Leiomyomas: A Randomized Clinical Trial. JAMA Dermatol 151:1096-102|